Re: CES as an easy and effective cost-reducing adjunct to ...

[Guest guest]

,

brains can be in states of a vast spectrum - that`s the main problem why the reactions to any sort of therapy are so different:

stable and rigid, stable and flexible, unstable and rigid, unstable and flexible, and all states between.

There are only two scientific models which describe approximately well the behaviour of our brains:

- deterministic chaos theory and

- the theory of dissipative structures

These are complex enough, however we get a certain order into brain behaviour.

Uwe

[Guest guest]

addendum:

that`s why an unstable and/or a flexible brain may react more sensitively to CES than a rigid/stable brain. When I tried CES for a while, I had been in a stable and flexible state. It was a feeling of easy going and relaxed/awake. After ending my CES training nothing had changed.....

Uwe

[Guest guest]

Do you think the same applies for neurofeedback? In other words, would an

unstable and/or a flexible brain react to NF better than a rigid/stable brain?

Just curious.

Rene

>

> addendum:

> that`s why an unstable and/or a flexible brain may react more sensitively

> to CES than a rigid/stable brain. When I tried CES for a while, I had been

> in a stable and flexible state. It was a feeling of easy going and

> relaxed/awake. After ending my CES training nothing had changed.....

> Uwe

>

[Guest guest]

Rene,

a good question. It certainly deserves a detailed study. CES mechanism is absolutely different from NF. I cannot judge how it works for the brain in detail. However I try a short answer to your question following the laws of chaos theory - which are generally valid:

if a stable brain has a big flexibility, you can train any method - even if it reaches deep (brain stem) structures - it won`t provoke big changes. This type of brain always returns to its initial healthy state. Maybe there is a gain, the story is like slow evolution, no revolution.

Opposite to it you get major changes if you train a rigid or unstable brain. However the rigidity must be in a final state just before it bursts. The problem is you have to push the brain into intermediate chaos. Only in this state you have the chance for big changes. Usually the chance for reaching a new healthier state is 50:50. Good boundary condition ameliorate these numbers.

Uwe

[Guest guest]

Is it not obvious that you should not be focussed too much on training the brain but be more aware or conscious of yourself/your body/your life/your thoughts feelings behaviour attitudes soul etc.in your everyday life and then the brain will follow.........you are not your brain..........it is the intermediair of the spirit............you might as well take a pill.........? (there is nothing wrong with pills but they are just pills).

[Guest guest]

My theory is that CES will help my son be more receptive to NFB training, but I

will have to wait awhile until I start training again.

For kids who have early trauma (adoption) history, the brain stem is the most

vulnerable link for them. I wonder what it would have been like when I was

experiencing so much sensitivity to multiple protocols (and finally could only

train with Othmer Low Frequency) if someone would have mentioned, " hey maybe CES

could help. " All I know is that I am glad I found it now, and it was really by

stumbling over a post on this site in November.

Rene

>

> Rene,

> a good question. It certainly deserves a detailed study. CES mechanism is

> absolutely different from NF. I cannot judge how it works for the brain in

> detail. However I try a short answer to your question following the laws of

> chaos theory - which are generally valid:

> if a stable brain has a big flexibility, you can train any method - even if

> it reaches deep (brain stem) structures - it won`t provoke big changes.

> This type of brain always returns to its initial healthy state. Maybe there

> is a gain, the story is like slow evolution, no revolution.

> Opposite to it you get major changes if you train a rigid or unstable

> brain. However the rigidity must be in a final state just before it bursts.

The

> problem is you have to push the brain into intermediate chaos. Only in this

> state you have the chance for big changes. Usually the chance for reaching

> a new healthier state is 50:50. Good boundary condition ameliorate these

> numbers.

> Uwe

>

[Guest guest]

Training the brain, when it is done effectively, tends to have a different result from more palliative approaches which " push " brain activity into a different state.  It's not clear to me from these comments whether there are good examples of people using CES or AVE (often with great regularity over long periods of time) who are able to stop needing to use them.  Brain training is all about changing the stable patterns of electrical activity--or the metabolic capacity of an area--in a way that becomes the " new normal " .  Training stops.  The results continue or continue to grow.  I think the two may be complementary, but not so sure one substitutes for the other.

Pete-- Van Deusenpvdtlc@...http://www.brain-trainer.comUSA 305 433 3160BR 47 3346 6235

The Learning Curve, Inc.

On Wed, Jan 4, 2012 at 9:42 PM, Frans van den Berg <frans@...> wrote:

 

Is it not obvious that you should not be focussed too much on training the brain but be more aware or conscious of yourself/your body/your life/your thoughts feelings behaviour attitudes soul etc.in your everyday life and then the brain will follow.........you are not your brain..........it is the intermediair of the spirit............you might as well take a pill.........? (there is nothing wrong with pills but they are just pills).

[Guest guest]

Pete,

let`s push the discussion forward and illustrate with an example:

one major effect of any brain training is the new capability of the client to produce alpha (and more smr than before) with and without technical means. This is a new additional state for the brain. In this way we comply with the theories of chaos and dissipative structure. Continuing the training means strengthening the new neural pathways and eliminating those traumata which prevented alpha til then. In summa we get a bigger and richer agglomerate of brain states than before.

I think we have to follow the laws of chaos and dissipative structure, in some cases the steps are small and not visible for the trainer/therapist.

BTW I use AVE regularly though I`m able to relax without technical means. It`s more safe and easy.

If you train NF with a different goal than producing more alpha, you remove trauma and you allow the brain to enrich the spectrum of states generally. If you make a test the client wasn`t able to produce alpha before, however now it works though you didn`t train alpha explicitly.

Uwe

[Guest guest]

Uwe,Thanks for your explanation.   As long as it happens it makes sense to do it.  And it sounds like your approach got results.Most NF practitioners have seen cases where training results in an end to anxiety or anger or depression.  No further training required. Certainly NF builds new neural pathways. Any learning experience does that. What NF does uniquely is to change energy patterns in the EEG--create new habits as stable as the old ones had been.I personally haven't seen anyone among the people I've known who focused on CES and/or AVE who " finished " their training.  My observation has been that these " driver " modalities were able to change current experience, but they didn't't change the stable patterns.  I've always thought of it as the difference between someone driving you and someone teaching you to drive.  But my experience has certainly not been extensive.

I was asking whether people had experiences with stable resolution of these kinds of issues. Does the change stabilize or do you keep using them? How many sessions would you expect to get that kind of result?

Pete-- Van Deusenpvdtlc@...http://www.brain-trainer.comUSA 305 433 3160BR 47 3346 6235The Learning Curve, Inc.

On Thu, Jan 5, 2012 at 10:15 AM, <uwegerlach@...> wrote:

 

Pete,

let`s push the discussion forward and illustrate with an example:

one major effect of any brain training is the new capability of the client to produce alpha (and more smr than before) with and without technical means. This is a new additional state for the brain. In this way we comply with the theories of chaos and dissipative structure. Continuing the training means strengthening the new neural pathways and eliminating those traumata which prevented alpha til then. In summa we get a bigger and richer agglomerate of brain states than before.

I think we have to follow the laws of chaos and dissipative structure, in some cases the steps are small and not visible for the trainer/therapist.

BTW I use AVE regularly though I`m able to relax without technical means. It`s more safe and easy.

If you train NF with a different goal than producing more alpha, you remove trauma and you allow the brain to enrich the spectrum of states generally. If you make a test the client wasn`t able to produce alpha before, however now it works though you didn`t train alpha explicitly. 

Uwe

 

[Guest guest]

Pete,

I agree with you, my alpha example was just for illustration of chaos mechanism. In the case of severe and deeply located trauma, focussing only on alpha is not enough - I know this from my own therapy 25 years ago. In this context I remember Wises basic mind mirror pictures where alpha was always present in the high performance state. Only then (when sufficient alpha is present) the brain energy can flow up and down the whole spectrum.

In the case of minor trauma the alpha example is more realistic to produce new stable brain patterns. I`ve seen cases of AVE use for years. The persons told me that their pathological symptoms (allergies and others) had vanished.

For me important today is to find a general valid mechanism why NF works - a GUT, a general unified theory.

Chaos and dissipative structure of the brain are the basis, bur there must be something basically else/more...

If we find a GUT, we can do better and more convincing advertisement.

Uwe

[Guest guest]

My understanding and experience is that both neurofeedback and CES can be done

for a period of time and then can be withdrawn without a resurgence of symptoms.

This is not true of medications and AVE.

I willing to hear of experience or research that says that AVE can have enduring

effects.

Ames

AlertFocus.com

>

> Pete,

> let`s push the discussion forward and illustrate with an example:

> one major effect of any brain training is the new capability of the client

> to produce alpha (and more smr than before) with and without technical

> means. This is a new additional state for the brain. In this way we comply

with

> the theories of chaos and dissipative structure. Continuing the training

> means strengthening the new neural pathways and eliminating those traumata

> which prevented alpha til then. In summa we get a bigger and richer

> agglomerate of brain states than before.

> I think we have to follow the laws of chaos and dissipative structure, in

> some cases the steps are small and not visible for the trainer/therapist.

> BTW I use AVE regularly though I`m able to relax without technical means.

> It`s more safe and easy.

> If you train NF with a different goal than producing more alpha, you remove

> trauma and you allow the brain to enrich the spectrum of states

> generally. If you make a test the client wasn`t able to produce alpha before,

> however now it works though you didn`t train alpha explicitly.

> Uwe

>

[Guest guest]

Here are a few articles from Dave siever's web site at www.mindalive.com  There is also more information on his site about research studies that may give you some food for thought.

Sincerely, LevineOn Thu, Jan 5, 2012 at 11:03 AM, <garyames@...> wrote:

 

My understanding and experience is that both neurofeedback and CES can be done for a period of time and then can be withdrawn without a resurgence of symptoms. This is not true of medications and AVE.

I willing to hear of experience or research that says that AVE can have enduring effects.

Ames

AlertFocus.com

>

> Pete,

> let`s push the discussion forward and illustrate with an example:

> one major effect of any brain training is the new capability of the client

> to produce alpha (and more smr than before) with and without technical

> means. This is a new additional state for the brain. In this way we comply with

> the theories of chaos and dissipative structure. Continuing the training

> means strengthening the new neural pathways and eliminating those traumata

> which prevented alpha til then. In summa we get a bigger and richer

> agglomerate of brain states than before.

> I think we have to follow the laws of chaos and dissipative structure, in

> some cases the steps are small and not visible for the trainer/therapist.

> BTW I use AVE regularly though I`m able to relax without technical means.

> It`s more safe and easy.

> If you train NF with a different goal than producing more alpha, you remove

> trauma and you allow the brain to enrich the spectrum of states

> generally. If you make a test the client wasn`t able to produce alpha before,

> however now it works though you didn`t train alpha explicitly.

> Uwe

>

8 of 8 File(s)

article 6.pdf

article 11.pdf

article 4.pdf

article 5.pdf

article 7.pdf

article 3.pdf

article 1.pdf

article 2.pdf

[Guest guest]

Dear All,

In my journey of training, CES has notably realized the most immediate

results. I believe I have an insult to the brain stem, and I'm confident the

CES was part of the >20uv steady gamma waves in P3,P4,O1,O2 and >15uv steady

gamma in F3,F4,C3,C4 for this 20min. alpha-gamma synchrony design. I revisited

this design after running an 8 channel gamma increase design (which I got >150uv

gamma collectively in 8 sites) for 10 minutes, and I found I couldn't replicate

the gamma wave burst. During the initial alpha-gamma synchrony design (I

actually recorded this and the gamma increase session), notably, there was a

20Hz beta wave of >15uv at P3,P4,O1,O2 from the start, and the surge in gamma

bandwidth did not appear until about 6 minutes and continued for the duration of

the 20 min.

I realize this is a n=1 result, but I'm aligning with Uwe, theorizing a

balance equilibrium can take place after a chaotic re-shuffling, and possibly

this is what was being seen in the session.

Just my 2 cents~I think the book " MegaBrain " really propounds remarkable

improvements and relevant case histories,

Mike

[Guest guest]

Does the brain learn better when it is more relaxed? Does stress impede

progress with neurofeedback training? If the answer to these questions are yes,

or even a " maybe, " I think this is where CES can be an important adjunct therapy

for kids who have experienced early trauma and also for their parents.

Most of these kids (my son included) who come to therapy are anything but

relaxed. Because of the vulnerability with the brainstem , their neurohormones

(serotonin, dopamine, norepinephrine) are out of alignment, their adrenal system

is in fifth gear, and consequently their sympathetic nervous system doesn't know

the off switch. Add the gut and learning problems that often come with this

package, and you can imagine how this stress spills over to the household .

Even when kids start healing, parent have to learn how to stop being

hyper-vigilant since the parent's adrenal system has been frazelled to a thread

because they are used to having the next thing set their kid off.

So, I just wonder, if having a little support to regulate the brainstem upstream

would open the door to more efficient neurofeedback training for these kids.

It's more of a bottom- up approach. Many of the movement therapies

(Doman-Delacato, RMT, Handle) are also modeled after this design of starting

with the brainstem first and following up with other therapies like

neurofeedback.

Personally, we did two TLC assessments and tried 13 protocols, and every one

resulted is 24 hours of hell after each trial, except for FCz/A1/g/CPz/A2 (L).

The ones that didn't work included:

( T3/A1-1C 1 inhibit (15-38 hz) EC 5 min/20 min; T3/A1/G/ T4/A2;

FCz/A1/g/CPz/A2 (L); 2C squash, EO 2 /18 min; F7/A1/g/F8/A2; 2C squash EO 2/18

min; Cz/A1 1C beta% up (11-15 hz); C3/A1/g/C4/A2 2C squash EO 2/18 min;

P3/A1/g/P4/A2 Coherence Up (6-10 hz); 2C squash, EO 2 /18 min; FCz/A1/g/CPz/A2

(L); 2C squash, EO 2 /18 min.

We had originally trained with an Othmer provider and went back to those

ultra-low frequency protocols because they worked. (This is not an

advertisement for the Othmers—I would have loved to have other protocols work,

but in reality they didn't.)

I am just putting the suggestion out there that CES might be a helpful adjunct

tool in your practice if you are working with children who have had early

trauma. If it helps the brain (and family) be more relaxed, and the household

less stressful, I suspect that it will provide a more condusive environment to

train the brain and promote healing. And, if you aren't sure about it for

your kid clients, at least consider it for the parents.

Rene Kay

>

> > **

> >

> >

> > **

> > Pete,

> > let`s push the discussion forward and illustrate with an example:

> > one major effect of any brain training is the new capability of the client

> > to produce alpha (and more smr than before) with and without technical

> > means. This is a new additional state for the brain. In this way we comply

> > with the theories of chaos and dissipative structure. Continuing the

> > training means strengthening the new neural pathways and eliminating those

> > traumata which prevented alpha til then. In summa we get a bigger and

> > richer agglomerate of brain states than before.

> > I think we have to follow the laws of chaos and dissipative structure, in

> > some cases the steps are small and not visible for the trainer/therapist.

> > BTW I use AVE regularly though I`m able to relax without technical means.

> > It`s more safe and easy.

> > If you train NF with a different goal than producing more alpha, you

> > remove trauma and you allow the brain to enrich the spectrum of states

> > generally. If you make a test the client wasn`t able to produce alpha

> > before, however now it works though you didn`t train alpha explicitly.

> > Uwe

> >

> >

> >

> >

>

[Guest guest]

All,

I think Rene makes a good point, and there may be peak performance applications

as well. I just want to point to a web reference that supports the notion on the

importance of brain stem considerations, and just about covers CES, though all

the same, carries it in spirit:

http://www.sbwire.com/press-releases/sbwire-121348.htm

Reaching the Unreachable Brain

Bonners Ferry, ID -- (SBWIRE) -- 01/05/2012 -- Expanding knowledge of how the

brain operates can be used to treat young children who previously were

considered too damaged for healing. Using sophisticated brain mapping

techniques, healing therapies like music, drumming, riding and grooming horses,

immersion tank, neuro-feedback and more traditional therapies can be focused on

specific weaknesses in the brain to strengthen self regulation abilities.

" The brain is like the proverbial black box " stated Lon to his guest's

Zimmerman, founder of the Sandhill Child Center and Clinical Director, Dr. Kurt

Wulfekuhler. " The brain has been a mystery for so long and ever since the 90's;

there has been an explosion of research " agreed. And so began today's

topic: Reaching the Unreachable Brain, on Lon Woodbury's Internet Talk Radio

Show " Parent Choices for Struggling Teens " January 2, 2012 on LATalkRadio at

http://www.latalkradio.com.

With both of today's guest's having about thirty years experience working with

struggling and emotionally challenged adolescents, both and Dr. Kurt have

been using new and cutting edge techniques in working with children who were

unreachable before. With the use of key principals from brain research, they

have found that 1) the brain is hardwired based on past experiences, 2) the

brain develops from the bottom up and 3) the brain develops sequentially. From

there, a functional brain map is created by looking at the different areas of

the brain that haven't been developed or are in need of repair. The use of

repetitive interventions are used to create new patterns, with some actually

duplicating a maternal heart rate, such as drumming, touch, swimming and the use

of a recently acquired floatation tank, which duplicates the sensory input of

the womb. As Lon pointed out " this type of technique can be quite beneficial for

those children who are hypersensitive to even the feel of their clothing. "

Other techniques that are quite successful in working with children include

neurofeedback units that simulate video games, but use the child's brainwave

patterns instead of the use of joy sticks. These brain wave patterns are used as

EEG readings that can be monitored by therapists on the computer. Music,

movement, yoga, exercise and guided imagery are also positive forms of self

regulatory intervention methods. Relational interventions include animal

assisted therapy with the use of horses, cats and dogs and cognitive therapies

focus on speech and language techniques. Once again, Dr. Kurt explained " this

framework of interventions start at the bottom of the brain stem " , or as

phrased it " it is comparable to the foundation of a house, the bottom needs to

function correctly in order to work. "

On closing, shared " that working and developing the models used at

Sandhill Child Development Center has been a very rewarding experience and it is

fascinating how the brain impacts everything we do. "

To listen to the whole interview on Reaching the Unreachable Brain, go to

LATalkRadio at http://www.latalkradio.com/Players/Lon-010212.shtml.

Lon Woodbury as an Independent Educational Consultant is the owner/founder of

Woodbury Reports Inc. and http://www.strugglingteens.com. He has worked with

families and struggling teens since 1984 and is the host of Parent choices for

Struggling Teens on LATalkRadio Mondays at 12:00 Noon, Pacific Time, Channel

One.

Zimmerman, MA, LPCC, is the founder/CEO of Sandhill Child Development

Center, located in New Mexico. has a long history of working in and

managing programs for young children. has worked in various residential

treatment programs, was director of another residential center and director of

social services in a hospital setting. Sandhill Child Development Center was

founded in 2004.

Dr. Kurt Wulfekuhler, PhD, is the Clinical Director for Sandhill Child

Development Center and has 30 years experience working with emotionally

disturbed children and is a specialist in attachment disorders. Dr. Wulfekuhler

has been in private practice for many years and has been with Sandhill for three

years.

About Woodbury Reports

Woodbury Reports was founded in November 1989, by Lon Woodbury, MA, IECA, CEP,

as an Independent Educational Consulting firm to help parents of teens making

poor decisions select a private, parent choice program that would help return

the family to normalcy. Through interviews with parents, communication with

professionals who know your child well, and then thoroughly researching viable

options, we can help parents make the right choices that will help your child

get back on the right path. For more information about Woodbury Reports Inc.,

call 208-267-5550, or email to lon@..., or visit the web site

http://www.strugglingteens.com.

> >

> > > **

> > >

> > >

> > > **

> > > Pete,

> > > let`s push the discussion forward and illustrate with an example:

> > > one major effect of any brain training is the new capability of the client

> > > to produce alpha (and more smr than before) with and without technical

> > > means. This is a new additional state for the brain. In this way we comply

> > > with the theories of chaos and dissipative structure. Continuing the

> > > training means strengthening the new neural pathways and eliminating those

> > > traumata which prevented alpha til then. In summa we get a bigger and

> > > richer agglomerate of brain states than before.

> > > I think we have to follow the laws of chaos and dissipative structure, in

> > > some cases the steps are small and not visible for the trainer/therapist.

> > > BTW I use AVE regularly though I`m able to relax without technical means.

> > > It`s more safe and easy.

> > > If you train NF with a different goal than producing more alpha, you

> > > remove trauma and you allow the brain to enrich the spectrum of states

> > > generally. If you make a test the client wasn`t able to produce alpha

> > > before, however now it works though you didn`t train alpha explicitly.

> > > Uwe

> > >

> > >

> > >

> > >

> >

>

[Guest guest]

Full Disclosure: this is the main reason this is top of mind, and my wish to

support as an advocate <in case this dropped off your news-cycle feed> <I also

tread vocationally in the pharmaceutical arena, so I know the potential impact

of this>-

http://www.bmedreport.com/archives/30989

Cranial Electrotherapy Stimulation (CES) Call To Action – Healthcare Providers

Are Urgently Requested To Contact FDA

On August 28, 2011, in Electrotherapy, Political | Legal, submitted by

Fisher, PhD

FDA website Electromedical Products International Inc. (EPI) issued an urgent

call-to-action this past week for practitioners who prescribe Alpha-Stim to

their patients. The complete details and formal announcement from Tracey B.

Kirsch, President of EPI are below. Briefly, the Food and Drug Administration

(FDA) intend to review current evidence for the safety and effectiveness of

Alpha-Stim. The FDA posted a notice whereby this matter is now open for public

comment, and EPI asks that those who prescribe/use Alpha-Stim to get involved.

If the FDA ignores the current positive and plentiful safety/effectiveness data,

which they appear set to do, this could mean that Alpha-Stim is removed from the

United States' market until EPI goes through a lengthy and expensive FDA

validation process. EPI invites all clinicians and patients who use Alpha-Stim

to get involved. Included in this report are detailed instructions on how to get

involved, including a suggested letter template and additional background

information on this issue.

On a personal note, I am saddened to see this safe and effective product as well

as the good folks at EPI to be subjected to this treatment. Alpha-Stim has been

used safely in United States for 30 years with no known major side effects. I

know this first hand because my first PhD dissertation was with Alpha-Stim, and,

although I did not carry out the study, my research design was adapted by

Tan, PhD at Department of Veteran Affairs, E. DeBakey VA Medical

Center, in Houston, Texas – the study is ongoing. I find it bewildering that the

FDA holds this safe alternative treatment to an excessively high standard when

there are numerous medications currently on the market that can cause serious

and permanent side effects, including death. In fact, last I checked, Alpha-Stim

is so safe that it is sold over-the-counter in Europe.

Here is EPI's announcement:

Dear Friends of Alpha-Stim®,

On Monday, August 8, 2011 the US Food and Drug Administration (FDA)

published a Proposed Rule in the Federal Register (Volume 76, No. 152) regarding

cranial electrotherapy stimulation (CES). This action is directed to the entire

CES industry and not just Alpha-Stim CES. They have opened a 90 day public

comment period on CES. This 90 day period is for FDA to receive public comment

on the possibility of down-classifying CES from Class III to Class II or

requiring Pre-Market Approval (PMA) in the USA. At the end of this comment

period FDA will issue a final rule which will either down classify CES to Class

II or will call for all CES manufacturers to prepare PMA Applications. While FDA

conducts its review of these PMA's, legally cleared CES devices may remain on

the market in the USA.

EPI has been through this and similar FDA rulings many, many times over its

30 year history. We are confident in our ability to produce the necessary

science and safety data to meet the statutory requirements. However, FDA has

consistently acted in an arbitrary and capricious manner in regulatory reviews

submitted by EPI regarding CES. Because of this history we are not confident

that a fair review is possible by FDA and therefore there is a real risk of CES

being removed from the market in our country.

As always, EPI will comply with this rule making process under the guidance

of its expert legal team. We will pursue all means necessary, but we need your

assistance for CES to remain on the market in the USA. It is vital for the

public to take advantage of sharing with FDA, through this public comment

period, its opinion, whether expert or lay, of the effectiveness of Alpha-Stim

CES. In this proposed rule, FDA is asserting that CES is not effective and

therefore CES manufacturers should be required to complete the very expensive

and time consuming PMA process. This ruling notes a price tag of $1,000,000 for

the preparation of the PMA application by the sponsor (EPI) and an $8,490,000

cost to taxpayers for FDA to review the PMA's submitted as a result of this

action! It is EPI's expert opinion that there is more than ample scientific

evidence in existence to provide " reasonable assurance " that Alpha-Stim CES is

safe and effective for its indications.

Please share your comments regarding your experiences with CES, including

your opinion of harm that may be done to patients by removing this safe and

effective technology from the US market. Please forward your comments to the FDA

via the public docket as outlined in the Federal Register in the Electronic or

Written Submissions section on page 48062.

The following links [links are at the end of this report] will lead you to

the Monday, August 8, 2011 Federal Register notice, a Fact Sheet EPI prepared to

assist in breaking down the rule making process and the validity of FDA

assertions and for background information, we are providing a history of the

arbitrary and capricious regulatory handling of CES by the FDA in the last 30

years and the last link is to Dr. Kathy Platoni's expert opinion letter in

response to the Proposed Ruling. The EPI Team is embarrassed that our government

could produce such a misguided document under the guise of protecting public

health. We pray that our community of support will be able to save CES in the

USA! Please act now. We have until November 7, 2011 to be heard.

Please contact me or your Alpha-Stim Team member should you wish to discuss

this further or have any questions or concerns.

Sincerely,

Tracey B. Kirsch

President

How To Take Action – Instructions from EPI

If you find Alpha-Stim® to be an effective and safe tool for your practice or

for yourself, we invite you to share that information with FDA. EPI showing FDA

that CES works is good, practitioners and patients telling FDA that CES works is

great!

Step 1. If you would like to respond to FDA, you must click on the link below

and look at the " Submit a Comment " box in green at the upper right corner. You

can use this suggested letter template from EPI for your comments.

Step 2. You must add all this information to your comments (the Docket Number

must be in your filing):

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].

Step 3. All comments should be addressed to the signatory on the Proposed Rule:

K. Stade

Deputy Director for Policy, Center for Devices and Radiological Health.

Here is the link to upload your letter mentioned in Step 1 above:

http://www.federalregister.gov/articles/2011/08/08/2011-19957/effective-date-of-\

requirement-for-premarket-approval-for-cranial-electrotherapy-stimulator.

Step 4. Please also fax your letter to FDA at 301-827-6870 so they cannot say

they never received the upload.

Step 5. Please also send EPI a final copy of your letter to scott@... or

940.328.0888 (facsimile).

Thanks! EPI is asking that you simply tell FDA the truth about how safe and

effective CES is for you and/or your patients. EPI will deal directly with the

issues in the Proposed Rule. Thank you for your time and attention on this

important matter.

Need Help Or Have Questions?

If you have any questions or concerns please do not hesitate to contact:

Elder, Vice President (scott@... or 817-458-3279).

Additional Resources

FDA Prop Rule 2011-19957

Prop Rule Fact Sheet

FDA History Alpha-Stim CES

Colonel PLatoni Letter to FDA

Alpha-Stim Website

Alpha-Stim Research Summary

Financial Disclosure: BMED Report receives income from EPI for advertisements on

this website (this post is not an advertisement, but rather a genuine concern

for these recent developments).

> > >

> > > > **

> > > >

> > > >

> > > > **

> > > > Pete,

> > > > let`s push the discussion forward and illustrate with an example:

> > > > one major effect of any brain training is the new capability of the

client

> > > > to produce alpha (and more smr than before) with and without technical

> > > > means. This is a new additional state for the brain. In this way we

comply

> > > > with the theories of chaos and dissipative structure. Continuing the

> > > > training means strengthening the new neural pathways and eliminating

those

> > > > traumata which prevented alpha til then. In summa we get a bigger and

> > > > richer agglomerate of brain states than before.

> > > > I think we have to follow the laws of chaos and dissipative structure,

in

> > > > some cases the steps are small and not visible for the

trainer/therapist.

> > > > BTW I use AVE regularly though I`m able to relax without technical

means.

> > > > It`s more safe and easy.

> > > > If you train NF with a different goal than producing more alpha, you

> > > > remove trauma and you allow the brain to enrich the spectrum of states

> > > > generally. If you make a test the client wasn`t able to produce alpha

> > > > before, however now it works though you didn`t train alpha explicitly.

> > > > Uwe

> > > >

> > > >

> > > >

> > > >

> > >

> >

>