Guest guest Posted January 7, 2012 Report Share Posted January 7, 2012 This is a letter from a physician to the FDA regarding the use of CES. I think it has some important information if you are a user of CES equipment. JD Michel A. Woodbury-Fariña, MD 307 Eleanor Roosevelt Street San , Puerto Rico, 00918 October 24, 2011 K. Stade Deputy Director for Policy, Center for Devices and Radiological Health Food and Drug Administration 5630 Fisher Lane, Room 1061 Rockville, land 20852 Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule: “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.†[Docket No. FDA-2011-N-0504]. Dear Ms. Stade: I am submitting this response at the request of the Food and Drug Administration (FDA) in its Proposed Rule for Cranial Electrotherapy Stimulation (CES) issued in the Federal Register on August 8, 2011 (76 F.R. 152, p. 48062). As a clinical psychiatrist who not only owns Alpha-Stim products and uses them in my practice but also lectured on them and has published on this subject in the local Journal, I wanted to share with FDA my own findings on the efficacy and safety of CES. For the past four years, I have been using CES and Microcurrent Electrical Therapy (MET) treatments via the Alpha-Stim 100, personally, with my family, in my clinic and with my third year medical students. I am a practicing clinical psychiatrist with American Board of Psychiatry and Neurology certification in general, child and adolescent and geriatric psychiatry and licensed to practice medicine in Puerto Rico since 1983, the year I started my private practice. I am also an associate professor of psychiatry of the Department of Psychiatry of the University Of Puerto Rico School Of Medicine where I have worked part-time since 1984 and once held the position of Acting Chair. I have been the Principle Investigator in numerous pharmaceutical Phase II/III/IV field trials. I am also a Fellow of The American Institute of Stress. I have found that the effect the of the treatments of CES and MET with Alpha-Stim to be excellent, dependable and free of side effects as long as certain guidelines are followed. I first heard of the device through a bipolar patient of mine. He is a very anxious person who needs to use high doses of clonazepam to calm himself down. He had read about Alpha-Stim's effectiveness in anxiety and wanted to use CES for it. I agreed to give him the prescription for the Alpha-Stim SCS CES kit and he proceeded to use it when it arrived. He has found that his anxiety has decreased so much that he can significantly lower his clonazepam dose. This is 191 so much so that when he does get anxious I find out that he has not been using the device. I was then surprised to hear that he used the CES unit on his aunt, a severe bipolar II patient of mine who was in a very deactivated depression. He used the device to successfully pull her out of her depression. Thus I was convinced to try the unit myself and ended up using it with my family, with my patients and with my students. I have found that the main sign that a therapeutic effect is occurring on the CES is that the subject feels lightheaded. My wife and I do not feel lightheaded but do feel the dizziness if we go too high. This might be due to the fact that we do not become lightheaded with alcohol as I have seen that those who do will feel lightheaded on CES. However, I feel a positive, calming effect in myself. My wife uses it to deal with the pain of migraines, sometimes even stopping the progression at the "aura" stage. In my practice I have used it from 1 to 20 times on almost 1000 patients ranging from 6 to 75 years of age. I have an outpatient private practice of mostly children and adults with ADHD and adults with anxiety and depression. In my research projects I see schizophrenic adults. In my clinic I do psychotherapy and medication management. Ever since I received the first unit, I have used the CES unit on all of my patients as part of the therapy sessions at no extra cost. I have seen positive results of this treatment in cases of anxiety, depression, insomnia and in the few cases of pain that I see. The most dramatic effect of this unit is the way a panic level anxiety can be relieved in seconds. I can have a patient come in with the maximum Likert item visual analog scale of anxiety score of 10 out of 10 where 10 is the most intense anxiety and the patient is at 10. This totally acceptable use of Likert item scales. When the anxious person feels the lightheadedness, all tell me the anxiety comes down to zero out of 10. I found out that 20 minutes of this lightheadedness state will result in going the rest of the day without anxiety. I have seen this at all ages. One six year old anxious boy was brought in by his mother because he could not tolerate going to school because of his anxiety. He was able to go back to school that morning after a 20 minute CES session. One adult female was able to have her panic over going to a child support court appearance, after the appointment that same day, totally relieved after one CES session. I have used CES to decrease psychotic anxiety. In one schizophrenic the voices stopped. In another the anxiety decreased but the voices did not. In two others, both severely psychotic, the CES device did not help much. I have seen that the relief from depression is seen after a longer period. The average time to see changes are from 4 to 6 weeks. A 40-year-old depressed recovered heroin addict on methadone and Prozac with a moderate depression with an almost schizoid personality went through a one hour a week session for six weeks. At the end of this, her depression had abated and had become so gregarious that she started a romantic relationship with a man and they soon started living together. One 75 year old had her Ham-D score decrease significantly with daily use of Alpha- Stim CES for 20 minutes a day after four weeks. I ask all my patients who go through the CES treatment in my office or at school to remember how they sleep that night. Without exception all tell me they slept soundly including the medical students. Two depressed patients have told me that their insomnia has been relieved with daily CES use and that they felt their sleep was very restorative 192 .. As part of an introductory lecture on the mental status exam that I give to third year UPR medical students for their psychiatry rotation, I have put the CES device on over 300 medical students, 100 on for 5 minutes and 200 on them for over 20 minutes as I give the lecture. All feel very relaxed when they feel lightheaded, even those who had it for 5 minutes. All could continue listening while on the device. This intervention has consistently been positively evaluated by them. Many even wish the Department had an Alpha-Stim Clinic where they could go to before or after tests and relax. I personally am trying to get this clinic going. Special considerations I have seen that in order to have a positive effect with the CES, the subject has to feel lightheaded. This is a very difficult symptom to describe to the subject until they feel it. I sometimes have to use the word "float" to describe it. As I start to increase the micro-amps very slowly they first think the effect has to do with the occasional sensation of currents that are felt to be as if the clips were squeezing the ear lobes. (Some are bothered by this feeling of electricity. For these, my first intervention is to open and close the clips, which is usually successful. Rarely the feeling is intolerable. In this case I use the pads and put one behind each ear. This intervention has always been sucessful). Then when they "float" they are surprised as they notice the difference. If two clips do not do this at the maximum intensity I put on four clips to ensure that lightheaded feeling. This is a procedure that I have pioneered and I call it the "W technique" which can only be done on the Alpha-Stim 100 unit. This technique does require some calibration but it consists of finding out which combination of the clips give the most lightheadedness. While it is fine to "float," no one can be allowed to feel dizzy, vertigo or even to sense that the room seems to be moving or as if they are on a hammock or a boat. The setting of the microamps of the instrument has to be meticulously followed. When they "float" I ask them if they feel comfortable and make sure that they are not dizzy as many "float" and feel dizzy. Even after a successful "float" I will ask throughout the session if they feel the "float" or if they feel dizzy. If not floating, I increase the micro-amps. If there is any sign of dizziness or a sense of rocking, I lower the intensity. Many times when I start and the subject feels immediately very dizzy I bring the micro-amp intensity down to the lowest level of .5. Many continue to float at this level. One of the first patients to try the CES unit wanted to see what would happen if she stayed in the "dizzy" state. After five minutes of feeling dizzy, she became so nauseous she threw up. This is the only bothersome side effect, one that can easily be avoided. If the subject on CES inadvertently feels the dizziness or even if they feel they are swaying to and fro for an extended time, they can feel nauseous and even suffer headaches the rest of the day. Another cause of headaches is if the subject does not stay on CES for at least 20 minutes. For instance, at first I only put the CES unit on the medical students for five minutes so they would get a taste of the effect. However approximately 1/10 complained of headaches later that day and the next as well as some lingering dizziness. However for over 2 years now I have made sure that they remain on the CES unit for at least 20 minutes. Up to now no medical student has complained of any residual effects. As for headaches during the session, I had some medical students develop headaches in the first few minutes. However these headaches would disappear by the 20th minute. 193 In my practice, two subjects became irritable after they felt dizzy. One had an excellent experience the first time and then was irritable the second. The other felt very dizzy, pulled off the clips prematurely and refused to go through the 20 minute session. He remained upset for about one hour. In over 1000 subjects who have used this, only two have neither felt the lightheadedness nor dizziness at even the highest dose and did not feel any different after using the unit. One is a severe bipolar adolescent patient who has the most severe antisocial personality disorder in all my practice. The other is taking the highest dose of Xanax in all my practice. Note: I have very few patients on Xanax. I cannot explain why these two did not respond. I am not a pain specialist but having done a medical/surgical internship at L.A. County/University of Southern California Medical Center, I can handle simple pain syndromes. I have treated approximately 40 patients with pain on a one visit/intervention basis with both CES and MET. I find that migraine and fibromyalgia pain decrease with the use of CES. Many times tense, painful neck muscles can be relieved with CES alone. If the CES is not sufficient or if the pain is too intense I use the MET. Simple painful muscle spasms can be eliminated in minutes. Joint sprains and recent onset low back pains can also be attenuated with MET. All MET sessions are followed by CES sessions. None of these patients complained of any side effects during or after the CES or MET treatments. In summary, this device has added a new dimension to my practice. I can quickly resolve crises that usually involve high anxiety with the CES Alpha-Stim device without having to use benzodiazepines. I even have patients come in for unscheduled treatments when they feel that they cannot control their anxiety. This way I have been able to prevent a few hospitalizations with this approach. Thank you for your attention to this matter. It is my hope that FDA will allow CES to be downclassified to a Class II device as it has proven itself to be both safe and effective. Michel A. Woodbury-Fariña, MD 194 1 K. Stade Deputy Director for Policy, Center for Devices and Radiological Health Food and Drug Administration 5630 Fisher Lane, Room 1061 Rockville, land 20852 Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule: “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.†[Docket No. FDA- 2011-N-0504]. Dear Ms. Stade, I am a practicing occupational medicine physician who has been using Cranial Electrotherapy on patients for over three years with excellent results and no significant adverse effects. I had also reviewed an extensive amount of medical research literature on CED before I made the decision to prescribe it to my patients and to recommend it to other physicians. I was quite surprised to hear about FDA's current position of demanding a new PMA for CES. From my own use and my knowledge of the medical literature, this is a safe, efficacious and costeffective treatment for depression, anxiety, insomnia and for pain management. CES can be bought over-the-counter in Europe and in Asia, and my understanding is that the US military is using it widely to treat wounded veterans. CES had been used widely for over 30 years and has a very safe profile. I’m disheartened that the FDA would take such a stand concerning an efficacious and safe non pharmaceutical treatment and yet endorse use of numerous dangerous medications even though there is scant high quality medical research evidence that use of many of those medications are efficacious, and when there is evidence that use had resulted in significant mortality and morbidity—Oxycontin is a good example. I previously have served on the Board of Scientific Counselors to NIOSH (2003-06), and was involved in the initial development of the American College of Occupational and Environmental Medicine (ACOEM) evidence based practice guidelines. I also chaired the Treatment Guidelines Ad Hoc Committee for the Texas State Workers Compensation Division which investigated evidence based treatment guidelines, requested by the Texas State Legislature. (2005) From those activities, it was readily apparent that much (even most) of mainstream medical treatments are not supported by high quality medical research, yet are recommended in evidence based treatment guidelines even though studies regarding efficacy are of poor quality or lack power, or are based on ‘expert consensus’ because there are so few studies available regarding many treatments, including common ones. For example, the Official Disability Guideline is widely used clinically in the United States and is even mandated to be used for workers compensation cases in many states, including Texas. The majority of the recommendations of ODG, as is the same for other practice guidelines, are not supported by high quality research studies, and medical recommendation is based predominantly on ‘expert’ 195 2 consensus. I first became aware of Cranial Electrotherapy three years ago when I was asked to review the medical literature on it for Whole Foods Market, Inc. when it was under consideration as a covered treatment option for their employees. My review of the research on CES for them supported that it was both effective and safe as a treatment option for depression, anxiety, insomnia, and for pain management. In the past three years I have used and prescribed cranial electrotherapy for a large number of patients with excellent or good results for the majority of them. None of my patients have experienced adverse medical outcomes. My extensive review of the research literature prior to my decision to prescribe CES to patients found no evidence to suggest that use of the device as recommended was likely to cause adverse or serious effects. As a medical physician, I would urge you to reconsider your stand. Sincerely, V.Jane Derebery,MD,FACOEM Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 7, 2012 Report Share Posted January 7, 2012 Very interesting. Apparently the FDA is looking at reclassifying CES in a way that has the potential to reduce the availability of CES devices in the United States:http://bio-medical.com/news/2011/08/fda-and-ces-a-call-to-action/ http://www.bmedreport.com/archives/30989 http://www.emergogroup.com/blog/2011/11/fda-panel-sets-meeting-date-discuss-ces-reclassification Chivers>> This is a letter from a physician to the FDA regarding the use of CES. I think it has some important information if you are a user of CES equipment.> JD> > Michel A. Woodbury-Fariña, MD> 307 Eleanor Roosevelt Street> San , Puerto Rico, 00918> October 24, 2011> > K. Stade> Deputy Director for Policy,> Center for Devices and Radiological Health> Food and Drug Administration> 5630 Fisher Lane, Room 1061> Rockville, land 20852> > Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule:> “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy> Stimulator.†[Docket No. FDA-2011-N-0504].> > Dear Ms. Stade:> I am submitting this response at the request of the Food and Drug Administration (FDA) in its> Proposed Rule for Cranial Electrotherapy Stimulation (CES) issued in the Federal Register on> August 8, 2011 (76 F.R. 152, p. 48062). As a clinical psychiatrist who not only owns Alpha-Stim> products and uses them in my practice but also lectured on them and has published on this> subject in the local Journal, I wanted to share with FDA my own findings on the efficacy and> safety of CES.> For the past four years, I have been using CES and Microcurrent Electrical Therapy (MET)> treatments via the Alpha-Stim 100, personally, with my family, in my clinic and with my third> year medical students. I am a practicing clinical psychiatrist with American Board of Psychiatry> and Neurology certification in general, child and adolescent and geriatric psychiatry and licensed> to practice medicine in Puerto Rico since 1983, the year I started my private practice. I am also> an associate professor of psychiatry of the Department of Psychiatry of the University Of Puerto> Rico School Of Medicine where I have worked part-time since 1984 and once held the position> of Acting Chair. I have been the Principle Investigator in numerous pharmaceutical Phase> II/III/IV field trials. I am also a Fellow of The American Institute of Stress. I have found that the> effect the of the treatments of CES and MET with Alpha-Stim to be excellent, dependable and> free of side effects as long as certain guidelines are followed.> I first heard of the device through a bipolar patient of mine. He is a very anxious person who> needs to use high doses of clonazepam to calm himself down. He had read about Alpha-Stim's> effectiveness in anxiety and wanted to use CES for it. I agreed to give him the prescription for> the Alpha-Stim SCS CES kit and he proceeded to use it when it arrived. He has found that his> anxiety has decreased so much that he can significantly lower his clonazepam dose. This is> 191> so much so that when he does get anxious I find out that he has not been using the device. I was> then surprised to hear that he used the CES unit on his aunt, a severe bipolar II patient of mine> who was in a very deactivated depression. He used the device to successfully pull her out of her> depression. Thus I was convinced to try the unit myself and ended up using it with my family,> with my patients and with my students.> I have found that the main sign that a therapeutic effect is occurring on the CES is that the> subject feels lightheaded. My wife and I do not feel lightheaded but do feel the dizziness if we go> too high. This might be due to the fact that we do not become lightheaded with alcohol as I have> seen that those who do will feel lightheaded on CES. However, I feel a positive, calming effect> in myself. My wife uses it to deal with the pain of migraines, sometimes even stopping the> progression at the "aura" stage. In my practice I have used it from 1 to 20 times on almost 1000> patients ranging from 6 to 75 years of age. I have an outpatient private practice of mostly> children and adults with ADHD and adults with anxiety and depression. In my research projects I> see schizophrenic adults. In my clinic I do psychotherapy and medication management. Ever> since I received the first unit, I have used the CES unit on all of my patients as part of the therapy> sessions at no extra cost. I have seen positive results of this treatment in cases of anxiety,> depression, insomnia and in the few cases of pain that I see.> The most dramatic effect of this unit is the way a panic level anxiety can be relieved in seconds. I> can have a patient come in with the maximum Likert item visual analog scale of anxiety score of> 10 out of 10 where 10 is the most intense anxiety and the patient is at 10. This totally acceptable> use of Likert item scales. When the anxious person feels the lightheadedness, all tell me> the anxiety comes down to zero out of 10. I found out that 20 minutes of this lightheadedness> state will result in going the rest of the day without anxiety. I have seen this at all ages. One six> year old anxious boy was brought in by his mother because he could not tolerate going to school> because of his anxiety. He was able to go back to school that morning after a 20 minute> CES session. One adult female was able to have her panic over going to a child support court> appearance, after the appointment that same day, totally relieved after one CES session. I have> used CES to decrease psychotic anxiety. In one schizophrenic the voices stopped. In another the> anxiety decreased but the voices did not. In two others, both severely psychotic, the CES device> did not help much.> I have seen that the relief from depression is seen after a longer period. The average time to see> changes are from 4 to 6 weeks. A 40-year-old depressed recovered heroin addict on methadone> and Prozac with a moderate depression with an almost schizoid personality went through a one> hour a week session for six weeks. At the end of this, her depression had abated and had become> so gregarious that she started a romantic relationship with a man and they soon started living> together. One 75 year old had her Ham-D score decrease significantly with daily use of Alpha-> Stim CES for 20 minutes a day after four weeks.> I ask all my patients who go through the CES treatment in my office or at school to remember> how they sleep that night. Without exception all tell me they slept soundly including the medical> students. Two depressed patients have told me that their insomnia has been relieved with daily> CES use and that they felt their sleep was very restorative> 192> .> As part of an introductory lecture on the mental status exam that I give to third year UPR> medical students for their psychiatry rotation, I have put the CES device on over 300 medical> students, 100 on for 5 minutes and 200 on them for over 20 minutes as I give the lecture. All feel> very relaxed when they feel lightheaded, even those who had it for 5 minutes. All could continue> listening while on the device. This intervention has consistently been positively evaluated by> them. Many even wish the Department had an Alpha-Stim Clinic where they could go to before> or after tests and relax. I personally am trying to get this clinic going.> Special considerations> I have seen that in order to have a positive effect with the CES, the subject has to feel> lightheaded. This is a very difficult symptom to describe to the subject until they feel it. I> sometimes have to use the word "float" to describe it. As I start to increase the micro-amps very> slowly they first think the effect has to do with the occasional sensation of currents that are felt to> be as if the clips were squeezing the ear lobes. (Some are bothered by this feeling of> electricity. For these, my first intervention is to open and close the clips, which is usually> successful. Rarely the feeling is intolerable. In this case I use the pads and put one behind each> ear. This intervention has always been sucessful). Then when they "float" they are surprised as> they notice the difference. If two clips do not do this at the maximum intensity I put on four clips> to ensure that lightheaded feeling. This is a procedure that I have pioneered and I call it the "W> technique" which can only be done on the Alpha-Stim 100 unit. This technique does require> some calibration but it consists of finding out which combination of the clips give the most> lightheadedness.> While it is fine to "float," no one can be allowed to feel dizzy, vertigo or even to sense that the> room seems to be moving or as if they are on a hammock or a boat. The setting of the microamps> of the instrument has to be meticulously followed. When they "float" I ask them if they feel> comfortable and make sure that they are not dizzy as many "float" and feel dizzy. Even after a> successful "float" I will ask throughout the session if they feel the "float" or if they feel dizzy. If> not floating, I increase the micro-amps. If there is any sign of dizziness or a sense of rocking, I> lower the intensity. Many times when I start and the subject feels immediately very dizzy I bring> the micro-amp intensity down to the lowest level of .5. Many continue to float at this level. One> of the first patients to try the CES unit wanted to see what would happen if she stayed in the> "dizzy" state. After five minutes of feeling dizzy, she became so nauseous she threw up. This is> the only bothersome side effect, one that can easily be avoided. If the subject on CES> inadvertently feels the dizziness or even if they feel they are swaying to and fro for an extended> time, they can feel nauseous and even suffer headaches the rest of the day. Another cause of> headaches is if the subject does not stay on CES for at least 20 minutes. For instance, at first I> only put the CES unit on the medical students for five minutes so they would get a taste of the> effect. However approximately 1/10 complained of headaches later that day and the next as well> as some lingering dizziness. However for over 2 years now I have made sure that they remain on> the CES unit for at least 20 minutes. Up to now no medical student has complained of any> residual effects. As for headaches during the session, I had some medical students develop> headaches in the first few minutes. However these headaches would disappear by the 20th> minute.> 193> In my practice, two subjects became irritable after they felt dizzy. One had an excellent> experience the first time and then was irritable the second. The other felt very dizzy, pulled off> the clips prematurely and refused to go through the 20 minute session. He remained upset for> about one hour.> In over 1000 subjects who have used this, only two have neither felt the lightheadedness nor> dizziness at even the highest dose and did not feel any different after using the unit. One is a> severe bipolar adolescent patient who has the most severe antisocial personality disorder in> all my practice. The other is taking the highest dose of Xanax in all my practice. Note: I have> very few patients on Xanax. I cannot explain why these two did not respond.> I am not a pain specialist but having done a medical/surgical internship at L.A.> County/University of Southern California Medical Center, I can handle simple pain syndromes. I> have treated approximately 40 patients with pain on a one visit/intervention basis with both CES> and MET. I find that migraine and fibromyalgia pain decrease with the use of CES. Many times> tense, painful neck muscles can be relieved with CES alone. If the CES is not sufficient or if the> pain is too intense I use the MET. Simple painful muscle spasms can be eliminated in minutes.> Joint sprains and recent onset low back pains can also be attenuated with MET. All MET> sessions are followed by CES sessions. None of these patients complained of any side effects> during or after the CES or MET treatments.> In summary, this device has added a new dimension to my practice. I can quickly resolve crises> that usually involve high anxiety with the CES Alpha-Stim device without having to use> benzodiazepines. I even have patients come in for unscheduled treatments when they feel that> they cannot control their anxiety. This way I have been able to prevent a few hospitalizations> with this approach.> Thank you for your attention to this matter. It is my hope that FDA will allow CES to be downclassified> to a Class II device as it has proven itself to be both safe and effective.> Michel A. Woodbury-Fariña, MD> 194> 1> K. Stade> Deputy Director for Policy,> Center for Devices and Radiological Health> Food and Drug Administration> 5630 Fisher Lane, Room 1061> Rockville, land 20852> Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule: “Effective Date of> Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.†[Docket No. FDA-> 2011-N-0504].> Dear Ms. Stade,> I am a practicing occupational medicine physician who has been using Cranial Electrotherapy on> patients for over three years with excellent results and no significant adverse effects. I had also> reviewed an extensive amount of medical research literature on CED before I made the decision to> prescribe it to my patients and to recommend it to other physicians.> I was quite surprised to hear about FDA's current position of demanding a new PMA for CES.> From my own use and my knowledge of the medical literature, this is a safe, efficacious and costeffective> treatment for depression, anxiety, insomnia and for pain management. CES can be bought> over-the-counter in Europe and in Asia, and my understanding is that the US military is using it widely to> treat wounded veterans. CES had been used widely for over 30 years and has a very safe profile.> I’m disheartened that the FDA would take such a stand concerning an efficacious and> safe non pharmaceutical treatment and yet endorse use of numerous dangerous medications> even though there is scant high quality medical research evidence that use of many of those> medications are efficacious, and when there is evidence that use had resulted in significant> mortality and morbidityâ€"Oxycontin is a good example.> I previously have served on the Board of Scientific Counselors to NIOSH (2003-06), and> was involved in the initial development of the American College of Occupational and> Environmental Medicine (ACOEM) evidence based practice guidelines. I also chaired the> Treatment Guidelines Ad Hoc Committee for the Texas State Workers Compensation Division> which investigated evidence based treatment guidelines, requested by the Texas State> Legislature. (2005)> From those activities, it was readily apparent that much (even most) of mainstream> medical treatments are not supported by high quality medical research, yet are recommended> in evidence based treatment guidelines even though studies regarding efficacy are of poor> quality or lack power, or are based on ‘expert consensus’ because there are so few studies> available regarding many treatments, including common ones. For example, the Official> Disability Guideline is widely used clinically in the United States and is even mandated to be> used for workers compensation cases in many states, including Texas. The majority of the> recommendations of ODG, as is the same for other practice guidelines, are not supported by> high quality research studies, and medical recommendation is based predominantly on ‘expert’> 195> 2> consensus.> I first became aware of Cranial Electrotherapy three years ago when I was asked to> review the medical literature on it for Whole Foods Market, Inc. when it was under> consideration as a covered treatment option for their employees. My review of the research on> CES for them supported that it was both effective and safe as a treatment option for> depression, anxiety, insomnia, and for pain management.> In the past three years I have used and prescribed cranial electrotherapy for a large> number of patients with excellent or good results for the majority of them. None of my> patients have experienced adverse medical outcomes. My extensive review of the research> literature prior to my decision to prescribe CES to patients found no evidence to suggest that> use of the device as recommended was likely to cause adverse or serious effects.> As a medical physician, I would urge you to reconsider your stand.> Sincerely,> V.Jane Derebery,MD,FACOEM> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 7, 2012 Report Share Posted January 7, 2012 Hi JD, nice find, thanks. RegardsNoel EastwoodPsychologist Canberra, AustraliaPh: 02 6162 0914Fax: 02 6162 0915Web: www.learnwiseaustralia.comPsychology, Counselling, Neurofeedback, Fast ForWordBioexplorer Training videos:- Creating your own Basic Protocols in Bioexplorer; Getting Started in Bioexplorer; Running and Screening Your Session in Bioexplorer, Neurofeedback systems.IMPORTANT:This email remains the property of Learnwise and Noel Eastwood Psychology. This email and any files transmitted with it are confidential and are intended solely for the use of the intended recipient. If you are not the intended recipient, distribution or reproduction of this email is prohibited. If you have received this email in error, you are requested to contact the sender and delete the email. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 9, 2012 Report Share Posted January 9, 2012 I found the text (below) on a forum (orginally from elixa.com) which would convince everybody (including me.....) about the usefulness of CES. From Dick Swaab came this link, a database with extracts of current scientific research about for instance neurofeedback: take a look on Pubmed: http://www.ncbi.nlm.nih.gov/pubmed?term=neurofeedback . Reading it a bit, now I feel finally secure about NF.......... Question: Using Ces when experiencing anxiety/stress etc........is it still wise to use NF by an experienced practioner at the same time? They go together? Which is better beating old pattern of stress and anxiety? gr - Frans From the forum: Q. What is the history of CES?A. At least two millennium ago, physicians used electric eels to relieve pain. Experimentation with low intensity electrical stimulation of the brain was first reported by Drs. Leduc and Rouxeau of France in 1902. Research on using what is now referred to as cranial electrotherapy stimulation (CES) for treatment of anxiety began in the Soviet Union during the 1950's, its primary focus being the treatment of sleep disorders, hence its initial designation as "electrosleep." Treatment of insomnia was soon overshadowed, however, by psychiatric application for depression and anxiety. Since then, it has been referred to by many other names, the most popular being transcranial electrotherapy (TCET) and neuroelectric therapy (NET).East European nations soon picked up CES as a treatment modality and its use spread worldwide. by the late 1960's, animal studies of CES had begun in the United States at the University of Tennessee and what is now the University of Wisconsin Medical school.These were soon followed by human clinical trials at the University of Texas Medical school in San and the University of Wisconsin Medical School. More studies have followed. At present, the number of human studies stands at 103. In addition, there are 18 experimental animal studies, all of which attest to the safety of CES.CES has been an international treatment modality for more than 50 years. Thousands of people worldwide continue to receive its benefits. The most extensive work on CES continues in Russia at the Pavlov Institute in St. sburg. But by no means is its use restricted to that part of the world. Current estimates are that there are between 50- 100,000 units in use globally. From a broad reading of published literature, no negative effects or major contraindications have been found from the use of CES to date, either in the U.S. or other parts of the world.Q. Who could benefit most from the use of CES?A. First and foremost, those suffering from stress in the form of depression, anxiety, and insomnia who seek an effective non- pharmacologic alternative. Secondly, those suffering from illnesses where stress constitutes a prime symptom.According to the American Academy of Family Physicians, stress-related problems account for 80-85% of all visits to medical offices. Research indicates that 80-85% of all diseases are caused by stress which plays a major role in aggravating up to 90% of all illnesses and some part in the development of every disease, from cancer to the common cold.It has been estimated that 80% of the populace of the United States react to life adjustment problems with the "flight" or "fight" anxiety reaction. And that a similar percentage of our hospitals are filled with persons who have channeled anxiety released energies into their bodies resulting in psychogenic illnesses.Among those illnesses are: substance abuse withdrawal syndrome (alcohol, street drugs, nicotine, prescription drugs), chronic fatigue syndrome including fybromyalgia, pre-menstrual syndrome, attention deficit disorder and hyperactivity, migraine and tension headaches, TMJ dysfunction, chronic pain, pre-competitive and performance anxiety, panic disorders, tic dolereaux, bruxism, stress induced asthma, hives, gastrointestinal disorders, ulcers or gastritis, and irritable bowel syndrome, to name a few.We would underscore, however, that CES is not a cure for these illnesses and does not represent itself as such. But by successfully addressing the anxiety, depression, and insomnia underlying these disorders, it can play a major role in the healing process.Q. Is CES then only for the "sick" and the "stressed-out ?"A. You don't have to be "sick" or "stressed-out" to use CES and realize its benefits. CES is a life-enhancing instrument of potential value to everyone. Its uses are wide ranging. Some people use it as an adjunct to meditation practice each morning. Others during peak stressor moments that hit unexpectedly in the course of a day. Who hasn't experienced those times when we are about to "lose it?" Putting the unit on in these situations even just briefly--perhaps for as little as ten minutes-- can help curb that anxiety and serve as a reminder that one needs to be with ones self in a different way.CES also represents a significant affirmation that you have the power within to change your mental state and that you are willing to take active steps to create the time and the space to do so.Many use CES as an assist to their creative work or in high stress situations. CES quiets the mind, making it especially helpful in preparing for examinations or as an accelerated learning tool, such as when memorizing blocks of material. For the athlete readying for competition, it helps create the state of relaxed awareness helping them enter the zone of maximum performance. Each person finds for themselves how to best incorporate CES into their daily routineQ. Can CES be used as a sleep aid?A. The 100 Hz CES unit can be used at bedtime. But the .5 Hz CES needs to be employed differently.Because of the increased alertness resulting almost immediately from its use, some patients may find it difficult to fall asleep immediately after a treatment. Accordingly it is recommended that the .5 Hz CES application be done at least three hours before going to bed. But by no means does that mean that it is contraindicated for insomnia.One thing CES users often report is an increase in vivid dreaming. This results from compensation for lost REM sleep. As your sleep pattern begins to normalize--within the next two or three nights--it should become less frequent.Q. Does CES work for everyone?A. No. But it is known to be significantly effective for about 95% of the people who use it.Q. What can I expect ?A. Most people will experience a relaxation response almost immediately after treatment begins with a CES unit. Immediately after a CES treatment, patients usually report feeling relaxed and sometimes inebriated for the first few minutes. This is a pleasant and very comfortable sensation. After several minutes to hours, the light-headed feelings usually disappear, the relaxed state remains and a profound sense of alertness is achieved.This relaxed/alert state will usually remain for an average of 12 to 72 hours after the first few treatments. With regular use it is possible for the patient to habituate to this preferred state of consciousness. Some patients describe the CES experience as analogous to having a type A mind in a type B body.During the treatment some people will notice a subjective change in their body weight. You might feel heavier at first and then lighter, or you may simply feel lighter initially. You could feel slightly worse during the heavy cycle, and this feeling could last for days unless extra treatment time is given. Therefore it is important to continue the treatment for a few extra minutes if you should feel heavier at the end of the allotted time, even if it has already been twenty minutes or more. Continue for at least two minutes after you feel lighter. Although this is quite common, not everyone will be aware of these weight perception changes.Q. What long range changes should I expect?A. Sleep patterns should begin to normalize within the first day or two, with less and shorter periods of awakening during the night, faster onset of sleep after going to bed, and a greater feeling of being rested upon awakening the following morning. Depression and mood swings become less, as does irrational anger, irritability, and poor impulse control. By the second week, cognitive processing is visibly enhanced. Mental confusion due to stress begins to subside as the ability to focus and concentrate on work becomes easier and more efficient. The ability to recall information and accelerate learning also begins to return to normal pre-stress levels as concentration and memory improve.Q. What is the suggested length and frequency of treatment?A. For the 100Hz unit the recommended usage is 30-45 minutes once or twice daily for the first month after which the frequency may be reduced to two or three times weekly once symptoms are reduced or eliminated entirely. The 0.5 Hz unit recommended usage is three times a week for twenty to forty minutes, although there are some who will benefit from a more frequent daily treatment. There are also some who will achieve the full benefits within ten minutes. Some dentists use it instead of nitrous oxide during dental procedures that last for hours .You yourself determine how to best incorporate CES into your daily routine. It can be used on waking in the morning and/or on going to bed at night and/or in response to stress situations. Individuals undergoing psychiatric treatment or rehabilitation for substance abuse often benefit from more frequent and prolonged application.Those suffering from severe anxiety and extremes of compulsive or addictive behavior may find it necessary to use it more frequently, perhaps several times daily. When symptoms of depression or anxiety have lessened or disappeared, it is still important to have access to the unit as a tool for relapse prevention on an as-needed basis. It is helpful to work in close conjunction with your physician/healthcare professional to determine the role CES plays in your overall treatment program.Q. Can you overuse the unit? / Are there any adverse effects from doing so?A. You can't really overuse it. There have been no reported adverse effects from more frequent use. The objective of CES is to return neurotransmitter activity to pre-stress homeostasis. Once attained, CES has no additional effect. Serving as a training wheels of sorts, CES helps you reprogram yourself. Rather than learning to rely on the unit, you learn instead how to refine and expand the art of self-regulation. CES teaches you to become more sensitively attuned to yourself and better understand your body and its needs.Along the way, you will intuitively come to know when CES is needed and when it is to be put aside. You alone will become the determinant of use, as regards both frequency and duration.During its usage, you will experience periods of relative calm and a sense of control. You may even succumb to a bit of self- congratulations. Seemingly, your CES unit appears destined for the bottom of a drawer. Life being what it is, however, just as you are ready to celebrate for successfully negotiating your personal terrain with skill and dignity--- Voila! New challenges appear from nowhere,--a veritable curveball from Hell. CES can help move you through those difficult transitions. Keep it handy. Incorporate it into your daily regimen.The continuing use of the unit allows for further refinement of stress management skills at newer and higher levels of complexity.Q. Is CES difficult to use? /How much technical skill does it take?A. Most CES units are user friendly. After having put on either the electrodes or the earclips and inserted the leadwire into the jack, it's all very simple. CES units either feature an on-off knob that also controls the amplitude (turning it to the right increases the amount of current) as in the 100 Hz devices. They use a button that turns the unit on and a side wheel that increases the amplitude (The Alpha Stim in addition displays the amount of micro-current being used from 1-6, each numeral representing one hundred microamperes). Start with a low current and gradually increase it. If the current is too high, the patient may experience a stinging at the electrodes, dizziness or nausea. If any of these symptoms occur, simply reduce the current and the symptoms will immediately subside. After a minute or two, try increasing the current again, but always keep it at a comfortable level. It's ok to feel the current providing it is not uncomfortable.Q. How does CES work?A. As is the case with numerous medications, including aspirin, the exact physiological mechanism by which CES works is not fully understood and is still the subject of research study. It is hypothesized that CES acts by direct stimulation of the brain in the hypothalmic area with specific electronic frequencies. Such stimulation causes the brain to manufacture various neurohormones that effect ones moods and emotions as well as ones cognitive capabilities back to a level of pre-stress homeostasis. For a more detailed hypothesis see "The Biolectrical Mechanism" under Research.Q. How does electromedicine such as CES differ from Western drug medicine?A. Western drug medicine relies primarily on chemistry to heal and control pain. Microcurrent electrical therapy (MET) is based on the concept that the biophysics underlying the chemistry also plays a significant role in regulating bodily processes. Using waveforms at a level of current similar to the body's own, MET bridges cellular communications helping reestablish the normal electrical flow.The concept of a bioelectrical control system is common to every form of healing ever developed in recorded history, except for drug medicine. The Chinese named bioelectricity chi; the Japanese called it ki, the Indians referred to it as prana, and the Russians, bioplasma. There are 75 trillion cells in the human body, each one having an electrical potential across its cell membrane, just like a battery. Though acknowledging this fact, Western medicine does not yet fully appreciate the natural healing powers of the body or the bioelectrical systems that control them. .Q. How is the current transmitted?A. The traditional 100Hz unit utilizes pre-gelled electrodes that snap on or attach to the end of leadwire that plugs into jack of the unit. The Brain Tuner (BT-5 and 6) employs a stethoscope shaped device that sits beneath the ears.The 0.5 Hz unit (Alpha Stim) uses "ear clips" with felt electrodes that adhere to the clips. Saturate the felt electrodes with saline solution and then apply them to the superior aspect of the earlobes as close to the jaw as possible.Q. Under what circumstances is CES best used?A. CES units generally come with a built-in belt-clip allowing you full freedom of movement. This allows you to use it just about anywhere and under a variety of circumstances, except those noted under the contraindications. You can do it at home while watching TV or at the office while doing your paperwork. Though of course you might not care to go out jogging with it on, but then again you might. But CES is more than an aside. It is also a reminder of the need to create inner quiet and reroute your mental traffic. You don't want to contribute to it further by treating CES as yet one more thing to do, squeezed in between other frenetic events in your life. Though you need not interrupt your usual activity for CES, its results are generally enhanced by setting aside a special time for its use alone.Q. How safe is CES?A. CES has an unblemished safety record. For a more detailed analysis of that record see "safety" under the research section.Cranial electrotherapy stimulators are generally limited to less than one milliampere (mA) of current. The Alpha-Stim 100 is an example of a CES device that employs very low intensity electrical current pulses (up to 600 microamperes). To put this into perspective, it takes one-half of an ampere to light an ordinary 60 watt light bulb. To truly compare the work done per second by these two different currents, we must multiply the currents by the respective voltages that drive them. The product current x voltage is a measure of the rate of generation of energy, and is referred to as the power output. By definition, when a device outputs 1 ampere of current with a 1 volt driving force, the power output of the device is 1 watt. Therefore for the Alpha-Stim 100, the maximum output is (600/1,000,000)amperes x 9 volts = 0.0054 watts, or about 11,000 times less power than the light bulb. Many people do not even feel this amount of current.This is current amplitude similar to that in the human body. The sole source of the current is a nine volt battery. Because the current is alternating, it sends bipolar current between the electrodes instead of unidirectionally, as would be the case with direct current. Hence there is a net cellular polarization of zero to the user. This is a safety factor of major importance.The Alpha-Stim in particular uses a very broad band of frequencies collectively known as harmonic resonance. This insures that the right frequency will be delivered to reestablish homeostasis within the bioelectrical system. The other frequencies pass harmlessly.Q. Is CES discomforting?A. CES is not to be confused with either ECT (electroconvulsive therapy) which uses a much greater amount of electricity to induce traumatic shock, or aversion therapy both of which are based on discomfort. With CES you should experience no discomfort whatsoever. The most that will ever be felt is a mild tingling sensation. If at any time the sensation proves too strong, the amplitude should immediately be reduced by a simple turnoff the knob or twist of the dial.Research shows CES to operate effectively at both lower and higher levels of stimulation as well as below the sensate threshold. accordingly, the patients may turn the amplitude to the point of sensation; then turn it down slightly below that point leaving it there during the session. You may also increase or decrease the amplitude at will without impairing the efficacy of the treatment. Your own comfort always dictates the setting of the treatment.Q. What is the relationship between CES and nutrition?A. There is a synergistic relationship between nutrients and CES. Think of the brain as a car battery, some cells of which may not be fully functioning. To achieve that end one needs both water and the trickle charge--This is analogous to the brain, amino acids and the CES. The brain uses amino acids as the raw materials, the building blocks or precursors with which to build its neurotransmitters. It is necessary for these amino acids to be present in the bloodstream in adequate amounts for the maximum impact/benefit of CES to be realized. These precursors, if present will be taken up and synthesized into neurohormones much more effectively when CES is added. These neurotransmitter precursor amino acids can be taken orally as food supplements.To experience an even more dramatic impact of CES, it should be done in conjunction with amino acid supplements, especially in those areas in which one is deficient. Ideally, you might first test to determine the nature of the neurotransmitter deficiency and then develop a regimen supplementing your diet with specific amino acids known to be precursors to them.Q. Are there any contraindications?A. There are no known contraindications for use of CES. However, there are circumstances in which its safety has not been tested. Accordingly, CES should not be used without on-going clinical supervision by severe depressives and those known to be epileptic, pregnant, or those using implanted electronic devices such as cardiac pacemakers or insulin pumps.There have, however, been instances where under such supervision CES has been employed successfully and where CES has been shown to reduce both the frequency and severity of seizures.Because of the feeling of induced relaxation that results while using CES, though, this relaxation response does not in any way impair reaction time, it is recommended that CES not be used while operating dangerous or complex equipment or while driving.CES treatment may result indirectly in increased blood flow to the brain. Hence its possible contraindication in recent hemorrhagic stroke patients. This same effect can cause brief increased blood flow beneath the electrodes behind the ears. This redness should not be cause for concern. This is an extremely rare occurrence. It is not a burn response and will go away shortly after the CES treatment is finished if it occurs at all.Perhaps three persons out of one hundred report a slight headache when using CES. This is usually alleviated by simply turning the current down. If the headache should recur during ordinary use, cease using the unit and consult with your health care professional.As with the use of any medical device, the physician/licensed practitioner should be informed of any medication or neurotransmitter blockers the patient is taking as well as the employment of cardiac pacemakers or other electronic devices as mentioned above.Q. What research is there as to the safety and effectiveness of CES?A. There are approximately 1,000 articles on CES therapy many of which are listed in four reviews put out by the Foreign Service Bulletin of the United States Library of Congress. This is in addition to the wealth of physiological and bio-engineering data on electrosleep and electroanesthesia in animals. As of this writing there are more than 100 research studies on CES in humans and 18 experimental animal studies. The efficacy of CES has been clinically confirmed through the use of 28 different psychometric tests. The significance of CES research for treating anxiety has also been reconfirmed through meta-analyses conducted at the University of Tulsa and at the Department of Health Policy and Management , Harvard University School of Public Health. The full body of research can be accessed at this website.Source:Elixa.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 9, 2012 Report Share Posted January 9, 2012 I know we're supposed to put this on-group conversation on CES to bed, but I'm wondering if anyone has used it for anxiety with kids with autism. Specifically I'm wondering about the short period of light headedness that is reported before the more "grounded" experience of relaxation. For kids who can have such a unusual bodily experiences to begin with, I'm wondering if this would be anxiety producing in and of itself and how the initial tingling at the ears would be received by children with tactile defensiveness? Any experiences?Sorry if this has already been addressed. I confess I haven't read every CES post. From: frans@...Date: Mon, 9 Jan 2012 13:36:03 +0100Subject: Re: Re: CES I found the text (below) on a forum (orginally from elixa.com) which would convince everybody (including me.....) about the usefulness of CES. From Dick Swaab came this link, a database with extracts of current scientific research about for instance neurofeedback: take a look on Pubmed: http://www.ncbi.nlm.nih.gov/pubmed?term=neurofeedback . Reading it a bit, now I feel finally secure about NF.......... Question: Using Ces when experiencing anxiety/stress etc........is it still wise to use NF by an experienced practioner at the same time? They go together? Which is better beating old pattern of stress and anxiety? gr - Frans From the forum: Q. What is the history of CES?A. At least two millennium ago, physicians used electric eels to relieve pain. Experimentation with low intensity electrical stimulation of the brain was first reported by Drs. Leduc and Rouxeau of France in 1902. Research on using what is now referred to as cranial electrotherapy stimulation (CES) for treatment of anxiety began in the Soviet Union during the 1950's, its primary focus being the treatment of sleep disorders, hence its initial designation as "electrosleep." Treatment of insomnia was soon overshadowed, however, by psychiatric application for depression and anxiety. Since then, it has been referred to by many other names, the most popular being transcranial electrotherapy (TCET) and neuroelectric therapy (NET).East European nations soon picked up CES as a treatment modality and its use spread worldwide. by the late 1960's, animal studies of CES had begun in the United States at the University of Tennessee and what is now the University of Wisconsin Medical school.These were soon followed by human clinical trials at the University of Texas Medical school in San and the University of Wisconsin Medical School. More studies have followed. At present, the number of human studies stands at 103. In addition, there are 18 experimental animal studies, all of which attest to the safety of CES.CES has been an international treatment modality for more than 50 years. Thousands of people worldwide continue to receive its benefits. The most extensive work on CES continues in Russia at the Pavlov Institute in St. sburg. But by no means is its use restricted to that part of the world. Current estimates are that there are between 50- 100,000 units in use globally. From a broad reading of published literature, no negative effects or major contraindications have been found from the use of CES to date, either in the U.S. or other parts of the world.Q. Who could benefit most from the use of CES?A. First and foremost, those suffering from stress in the form of depression, anxiety, and insomnia who seek an effective non- pharmacologic alternative. Secondly, those suffering from illnesses where stress constitutes a prime symptom.According to the American Academy of Family Physicians, stress-related problems account for 80-85% of all visits to medical offices. Research indicates that 80-85% of all diseases are caused by stress which plays a major role in aggravating up to 90% of all illnesses and some part in the development of every disease, from cancer to the common cold.It has been estimated that 80% of the populace of the United States react to life adjustment problems with the "flight" or "fight" anxiety reaction. And that a similar percentage of our hospitals are filled with persons who have channeled anxiety released energies into their bodies resulting in psychogenic illnesses.Among those illnesses are: substance abuse withdrawal syndrome (alcohol, street drugs, nicotine, prescription drugs), chronic fatigue syndrome including fybromyalgia, pre-menstrual syndrome, attention deficit disorder and hyperactivity, migraine and tension headaches, TMJ dysfunction, chronic pain, pre-competitive and performance anxiety, panic disorders, tic dolereaux, bruxism, stress induced asthma, hives, gastrointestinal disorders, ulcers or gastritis, and irritable bowel syndrome, to name a few.We would underscore, however, that CES is not a cure for these illnesses and does not represent itself as such. But by successfully addressing the anxiety, depression, and insomnia underlying these disorders, it can play a major role in the healing process.Q. Is CES then only for the "sick" and the "stressed-out ?"A. You don't have to be "sick" or "stressed-out" to use CES and realize its benefits. CES is a life-enhancing instrument of potential value to everyone. Its uses are wide ranging. Some people use it as an adjunct to meditation practice each morning. Others during peak stressor moments that hit unexpectedly in the course of a day. Who hasn't experienced those times when we are about to "lose it?" Putting the unit on in these situations even just briefly--perhaps for as little as ten minutes-- can help curb that anxiety and serve as a reminder that one needs to be with ones self in a different way.CES also represents a significant affirmation that you have the power within to change your mental state and that you are willing to take active steps to create the time and the space to do so.Many use CES as an assist to their creative work or in high stress situations. CES quiets the mind, making it especially helpful in preparing for examinations or as an accelerated learning tool, such as when memorizing blocks of material. For the athlete readying for competition, it helps create the state of relaxed awareness helping them enter the zone of maximum performance. Each person finds for themselves how to best incorporate CES into their daily routineQ. Can CES be used as a sleep aid?A. The 100 Hz CES unit can be used at bedtime. But the .5 Hz CES needs to be employed differently.Because of the increased alertness resulting almost immediately from its use, some patients may find it difficult to fall asleep immediately after a treatment. Accordingly it is recommended that the .5 Hz CES application be done at least three hours before going to bed. But by no means does that mean that it is contraindicated for insomnia.One thing CES users often report is an increase in vivid dreaming. This results from compensation for lost REM sleep. As your sleep pattern begins to normalize--within the next two or three nights--it should become less frequent.Q. Does CES work for everyone?A. No. But it is known to be significantly effective for about 95% of the people who use it.Q. What can I expect ?A. Most people will experience a relaxation response almost immediately after treatment begins with a CES unit. Immediately after a CES treatment, patients usually report feeling relaxed and sometimes inebriated for the first few minutes. This is a pleasant and very comfortable sensation. After several minutes to hours, the light-headed feelings usually disappear, the relaxed state remains and a profound sense of alertness is achieved.This relaxed/alert state will usually remain for an average of 12 to 72 hours after the first few treatments. With regular use it is possible for the patient to habituate to this preferred state of consciousness. Some patients describe the CES experience as analogous to having a type A mind in a type B body.During the treatment some people will notice a subjective change in their body weight. You might feel heavier at first and then lighter, or you may simply feel lighter initially. You could feel slightly worse during the heavy cycle, and this feeling could last for days unless extra treatment time is given. Therefore it is important to continue the treatment for a few extra minutes if you should feel heavier at the end of the allotted time, even if it has already been twenty minutes or more. Continue for at least two minutes after you feel lighter. Although this is quite common, not everyone will be aware of these weight perception changes.Q. What long range changes should I expect?A. Sleep patterns should begin to normalize within the first day or two, with less and shorter periods of awakening during the night, faster onset of sleep after going to bed, and a greater feeling of being rested upon awakening the following morning. Depression and mood swings become less, as does irrational anger, irritability, and poor impulse control. By the second week, cognitive processing is visibly enhanced. Mental confusion due to stress begins to subside as the ability to focus and concentrate on work becomes easier and more efficient. The ability to recall information and accelerate learning also begins to return to normal pre-stress levels as concentration and memory improve.Q. What is the suggested length and frequency of treatment?A. For the 100Hz unit the recommended usage is 30-45 minutes once or twice daily for the first month after which the frequency may be reduced to two or three times weekly once symptoms are reduced or eliminated entirely. The 0.5 Hz unit recommended usage is three times a week for twenty to forty minutes, although there are some who will benefit from a more frequent daily treatment. There are also some who will achieve the full benefits within ten minutes. Some dentists use it instead of nitrous oxide during dental procedures that last for hours .You yourself determine how to best incorporate CES into your daily routine. It can be used on waking in the morning and/or on going to bed at night and/or in response to stress situations. Individuals undergoing psychiatric treatment or rehabilitation for substance abuse often benefit from more frequent and prolonged application.Those suffering from severe anxiety and extremes of compulsive or addictive behavior may find it necessary to use it more frequently, perhaps several times daily. When symptoms of depression or anxiety have lessened or disappeared, it is still important to have access to the unit as a tool for relapse prevention on an as-needed basis. It is helpful to work in close conjunction with your physician/healthcare professional to determine the role CES plays in your overall treatment program.Q. Can you overuse the unit? / Are there any adverse effects from doing so?A. You can't really overuse it. There have been no reported adverse effects from more frequent use. The objective of CES is to return neurotransmitter activity to pre-stress homeostasis. Once attained, CES has no additional effect. Serving as a training wheels of sorts, CES helps you reprogram yourself. Rather than learning to rely on the unit, you learn instead how to refine and expand the art of self-regulation. CES teaches you to become more sensitively attuned to yourself and better understand your body and its needs.Along the way, you will intuitively come to know when CES is needed and when it is to be put aside. You alone will become the determinant of use, as regards both frequency and duration.During its usage, you will experience periods of relative calm and a sense of control. You may even succumb to a bit of self- congratulations. Seemingly, your CES unit appears destined for the bottom of a drawer. Life being what it is, however, just as you are ready to celebrate for successfully negotiating your personal terrain with skill and dignity--- Voila! New challenges appear from nowhere,--a veritable curveball from Hell. CES can help move you through those difficult transitions. Keep it handy. Incorporate it into your daily regimen.The continuing use of the unit allows for further refinement of stress management skills at newer and higher levels of complexity.Q. Is CES difficult to use? /How much technical skill does it take?A. Most CES units are user friendly. After having put on either the electrodes or the earclips and inserted the leadwire into the jack, it's all very simple. CES units either feature an on-off knob that also controls the amplitude (turning it to the right increases the amount of current) as in the 100 Hz devices. They use a button that turns the unit on and a side wheel that increases the amplitude (The Alpha Stim in addition displays the amount of micro-current being used from 1-6, each numeral representing one hundred microamperes). Start with a low current and gradually increase it. If the current is too high, the patient may experience a stinging at the electrodes, dizziness or nausea. If any of these symptoms occur, simply reduce the current and the symptoms will immediately subside. After a minute or two, try increasing the current again, but always keep it at a comfortable level. It's ok to feel the current providing it is not uncomfortable.Q. How does CES work?A. As is the case with numerous medications, including aspirin, the exact physiological mechanism by which CES works is not fully understood and is still the subject of research study. It is hypothesized that CES acts by direct stimulation of the brain in the hypothalmic area with specific electronic frequencies. Such stimulation causes the brain to manufacture various neurohormones that effect ones moods and emotions as well as ones cognitive capabilities back to a level of pre-stress homeostasis. For a more detailed hypothesis see "The Biolectrical Mechanism" under Research.Q. How does electromedicine such as CES differ from Western drug medicine?A. Western drug medicine relies primarily on chemistry to heal and control pain. Microcurrent electrical therapy (MET) is based on the concept that the biophysics underlying the chemistry also plays a significant role in regulating bodily processes. Using waveforms at a level of current similar to the body's own, MET bridges cellular communications helping reestablish the normal electrical flow.The concept of a bioelectrical control system is common to every form of healing ever developed in recorded history, except for drug medicine. The Chinese named bioelectricity chi; the Japanese called it ki, the Indians referred to it as prana, and the Russians, bioplasma. There are 75 trillion cells in the human body, each one having an electrical potential across its cell membrane, just like a battery. Though acknowledging this fact, Western medicine does not yet fully appreciate the natural healing powers of the body or the bioelectrical systems that control them. .Q. How is the current transmitted?A. The traditional 100Hz unit utilizes pre-gelled electrodes that snap on or attach to the end of leadwire that plugs into jack of the unit. The Brain Tuner (BT-5 and 6) employs a stethoscope shaped device that sits beneath the ears.The 0.5 Hz unit (Alpha Stim) uses "ear clips" with felt electrodes that adhere to the clips. Saturate the felt electrodes with saline solution and then apply them to the superior aspect of the earlobes as close to the jaw as possible.Q. Under what circumstances is CES best used?A. CES units generally come with a built-in belt-clip allowing you full freedom of movement. This allows you to use it just about anywhere and under a variety of circumstances, except those noted under the contraindications. You can do it at home while watching TV or at the office while doing your paperwork. Though of course you might not care to go out jogging with it on, but then again you might. But CES is more than an aside. It is also a reminder of the need to create inner quiet and reroute your mental traffic. You don't want to contribute to it further by treating CES as yet one more thing to do, squeezed in between other frenetic events in your life. Though you need not interrupt your usual activity for CES, its results are generally enhanced by setting aside a special time for its use alone.Q. How safe is CES?A. CES has an unblemished safety record. For a more detailed analysis of that record see "safety" under the research section.Cranial electrotherapy stimulators are generally limited to less than one milliampere (mA) of current. The Alpha-Stim 100 is an example of a CES device that employs very low intensity electrical current pulses (up to 600 microamperes). To put this into perspective, it takes one-half of an ampere to light an ordinary 60 watt light bulb. To truly compare the work done per second by these two different currents, we must multiply the currents by the respective voltages that drive them. The product current x voltage is a measure of the rate of generation of energy, and is referred to as the power output. By definition, when a device outputs 1 ampere of current with a 1 volt driving force, the power output of the device is 1 watt. Therefore for the Alpha-Stim 100, the maximum output is (600/1,000,000)amperes x 9 volts = 0.0054 watts, or about 11,000 times less power than the light bulb. Many people do not even feel this amount of current.This is current amplitude similar to that in the human body. The sole source of the current is a nine volt battery. Because the current is alternating, it sends bipolar current between the electrodes instead of unidirectionally, as would be the case with direct current. Hence there is a net cellular polarization of zero to the user. This is a safety factor of major importance.The Alpha-Stim in particular uses a very broad band of frequencies collectively known as harmonic resonance. This insures that the right frequency will be delivered to reestablish homeostasis within the bioelectrical system. The other frequencies pass harmlessly.Q. Is CES discomforting?A. CES is not to be confused with either ECT (electroconvulsive therapy) which uses a much greater amount of electricity to induce traumatic shock, or aversion therapy both of which are based on discomfort. With CES you should experience no discomfort whatsoever. The most that will ever be felt is a mild tingling sensation. If at any time the sensation proves too strong, the amplitude should immediately be reduced by a simple turnoff the knob or twist of the dial.Research shows CES to operate effectively at both lower and higher levels of stimulation as well as below the sensate threshold. accordingly, the patients may turn the amplitude to the point of sensation; then turn it down slightly below that point leaving it there during the session. You may also increase or decrease the amplitude at will without impairing the efficacy of the treatment. Your own comfort always dictates the setting of the treatment.Q. What is the relationship between CES and nutrition?A. There is a synergistic relationship between nutrients and CES. Think of the brain as a car battery, some cells of which may not be fully functioning. To achieve that end one needs both water and the trickle charge--This is analogous to the brain, amino acids and the CES. The brain uses amino acids as the raw materials, the building blocks or precursors with which to build its neurotransmitters. It is necessary for these amino acids to be present in the bloodstream in adequate amounts for the maximum impact/benefit of CES to be realized. These precursors, if present will be taken up and synthesized into neurohormones much more effectively when CES is added. These neurotransmitter precursor amino acids can be taken orally as food supplements.To experience an even more dramatic impact of CES, it should be done in conjunction with amino acid supplements, especially in those areas in which one is deficient. Ideally, you might first test to determine the nature of the neurotransmitter deficiency and then develop a regimen supplementing your diet with specific amino acids known to be precursors to them.Q. Are there any contraindications?A. There are no known contraindications for use of CES. However, there are circumstances in which its safety has not been tested. Accordingly, CES should not be used without on-going clinical supervision by severe depressives and those known to be epileptic, pregnant, or those using implanted electronic devices such as cardiac pacemakers or insulin pumps.There have, however, been instances where under such supervision CES has been employed successfully and where CES has been shown to reduce both the frequency and severity of seizures.Because of the feeling of induced relaxation that results while using CES, though, this relaxation response does not in any way impair reaction time, it is recommended that CES not be used while operating dangerous or complex equipment or while driving.CES treatment may result indirectly in increased blood flow to the brain. Hence its possible contraindication in recent hemorrhagic stroke patients. This same effect can cause brief increased blood flow beneath the electrodes behind the ears. This redness should not be cause for concern. This is an extremely rare occurrence. It is not a burn response and will go away shortly after the CES treatment is finished if it occurs at all.Perhaps three persons out of one hundred report a slight headache when using CES. This is usually alleviated by simply turning the current down. If the headache should recur during ordinary use, cease using the unit and consult with your health care professional.As with the use of any medical device, the physician/licensed practitioner should be informed of any medication or neurotransmitter blockers the patient is taking as well as the employment of cardiac pacemakers or other electronic devices as mentioned above.Q. What research is there as to the safety and effectiveness of CES?A. There are approximately 1,000 articles on CES therapy many of which are listed in four reviews put out by the Foreign Service Bulletin of the United States Library of Congress. This is in addition to the wealth of physiological and bio-engineering data on electrosleep and electroanesthesia in animals. As of this writing there are more than 100 research studies on CES in humans and 18 experimental animal studies. The efficacy of CES has been clinically confirmed through the use of 28 different psychometric tests. The significance of CES research for treating anxiety has also been reconfirmed through meta-analyses conducted at the University of Tulsa and at the Department of Health Policy and Management , Harvard University School of Public Health. The full body of research can be accessed at this website.Source:Elixa.com Quote Link to comment Share on other sites More sharing options...
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