This study is currently recruiting for, Chronic Fatigue Syndrome, (CFS)

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Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome,

Verified by town University, January 2010

First Received: December 17, 2008 Last Updated: February 1, 2010 History of

Changes

Sponsor: town University

Collaborators: National Institute of Environmental Health Sciences (NIEHS)

University of South Alabama

Information provided by: town University

ClinicalTrials.gov Identifier: NCT00810329

Purpose

The purpose of this study is:

To identify specific set of proteins in the cerebrospinal fluid (fluid

surrounding the brain and the spinal cord), that are believed to be seen in

Chronic fatigue syndrome (CFS) patients, but not in healthy controls (HC). A

similar study that the investigators had conducted before,suggested that

significant changes in proteins in the cerebrospinal fluid may be due to the

fundamental pathology of this disorder.

Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal

fluid to move around the brain and the spinal cord), may be related with certain

symptoms like headache, sleep problems, light headedness, increased pain,

excessive tiredness (fatigue) even with minimal work and memory problems.

Assessment of Autonomic Nervous system function (Sympathetic nervous

system)between the CFS and HC.

Perform Lung Function Testing or pulmonary function test to estimate the lung

capacities and score shortness of breath while performing breathing maneuvers.

Dolorimetry (18 tender point test) for assessment of pain threshold.

Capsaicin skin test

Allergy skin test

Condition

Chronic Fatigue Syndrome

Fibromyalgia

Gulf War Illness

Multiple Chemical Sensitivity

Interstitial Cystitis

Irritable Bowel Syndrome

Study Type: Observational

Study Design: Observational Model: Cohort

Time Perspective: Prospective

Official Title: Identify Unique Set of Proteins in Cerebrospinal Fluid, Which

Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in

Healthy Controls.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Fatigue Syndrome Fatigue Fibromyalgia

Interstitial Cystitis

U.S. FDA Resources

Further study details as provided by town University:

Primary Outcome Measures:

Differences in the proteins in the fluid around the brain, between Chronic

fatigue syndrome and Healthy subjects. These proteins may identify the disease

and define its mechanism. [ Time Frame: 3 - 4 years ] [ Designated as safety

issue: No ]

Secondary Outcome Measures:

Blood pressure differences in response to exercise, blood test and cerebrospinal

fluid, questionnaire results and sensory nerve testing to determine the role(s)

of altered nerve and brain function in Chronic fatigue syndrome. [ Time Frame:

3- 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Cheek swabs, on the right and left inner cheek. Others:Cerebrospinal fluid

samples,Blood samples Urine samples.

Estimated Enrollment: 150

Study Start Date: July 2007

Estimated Study Completion Date: April 2011

Estimated Primary Completion Date: April 2011 (Final data collection date for

primary outcome measure)

Groups/Cohorts

1

This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and

other conditions like Multiple chemical sensitivity, Irritable bowel syndrome,

Interstitial Cystitis, Gulf War Illness.

2

The healthy control group

Detailed Description:

Neurological dysfunction is a key component of the clinical expression and case

designation of chronic fatigue syndrome (CFS), fibromyalgia (FM)and other

related conditions.If the central nervous system is involved, then evidence will

be present in the cerebrospinal fluid. Distinct patterns of proteins will be

present in Chronic fatigue syndrome (CFS) compared to healthy control (HC)

subjects.

Other testing in our study would include:

a)Assessment of lung function and capacities. Additional interests are to assess

the shortness of breath, lightheadedness, headache and chest tightness during

the breathing maneuvers. The rationale for recording these symptoms is to

understand the pathophysiology of sensory disturbances that are more noted in

the CFS and Fibromyalgia group, but not in HC.

Compare the blood pressure and heart rate response before and after hand grip

exercise testing. This is a test to measure the Autonomic Nervous system

function (Sympathetic nervous system).

Skin tests like:

i) Capsaicin skin test, to check for specific responses like burning sensation,

area of skin redness, itchy sensation to varying doses of capsaicin (essence of

chilli pepper), when placed on the forearm and to compare if there are any

differences seen between the responses in CFS and Healthy controls.

ii) Allergy skin test to look if there are any allergies that are seen in the

set of CFS population.

18 tenderness point testing to compare the pain threshold before and after the

lumbar puncture also know as the spinal tap. 18 tenderness point testing is a

diagnostic test for Fibromyalgia.

Many of the participants with CFS do have associated Migraine headaches and they

complain of severe light and sound sensitivity. We are analysing those group of

people and decision have to be made as to which medications would work at best,

thus providing immediate relief from headache.

Eligibility

Ages Eligible for Study: 21 Years to 65 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

Sampling Method: Probability Sample

Study Population

town University Division of Rheumatology, Immunology and Allergy and other

Divisions

IRB-approved websites and support groups.

IRB- approved advertisments

Self-referral.

Criteria

Inclusion Criteria:

Chronic Fatigue Syndrome

Fibromyalgia

Gulf War Illness

Multiple Chemical Sensitivity

Irritable Bowel Syndrome

Interstitial Cystitis

Exclusion Criteria:

You do not want to have a lumbar puncture performed.

You have a severe physical impairment that does not permit lumbar puncture or

completion of the remainder of the tests (e.g. severe scoliosis or curvature of

the back).

You have a medical condition with symptoms similar to Chronic Fatigue Syndrome

such as regional pain syndromes, reflex sympathetic dystrophy, morbid obesity,

autoimmune / inflammatory diseases, cardiopulmonary disorders), neurological

disorders (e.g. seizures, dementia, degenerative disorders), uncontrolled

endocrine or allergic diseases or, cancer.

You have a severe psychiatric illness such as schizophrenia, substance abuse,

major depression with previous suicidal attempts, gestures or ideas about

committing suicide.

You are mentally retarded or cannot understand this informed consent, cannot

provide absolute willingness to have a lumbar puncture as part of this study, or

are unable to complete the questionnaires and other studies that are part of

this research project

You are in jail or prison.

You are pregnant.

You smoke more than 5 cigarettes per day. You will be allowed to taper your

smoking before your participation in the actual study visit. This is an

excellent opportunity to ask about our Smoking Cessation Programs.

You drink or eat caffeine containing products with more than the equivalent of 2

cups of coffee. You will be allowed to taper your caffeine intake before the

study visit.

You have used narcotics or other illegal medications for more than 3 months.

These will be discussed with Dr. Baraniuk.

You have a positive HIV test, or blood, liver or kidney tests that are abnormal.

You are participating only so you can be paid for taking part in this spinal tap

study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810329

Contacts

Contact: Murugan K Ravindran, MBBS cfsresearch@...,

look4murugan@..., mkr33@...

Contact: Yin Zheng, MS gwiresearch@...

Locations

United States, District of Columbia

town University Hospital, 3800 Reservoir Rd NW Recruiting

Washington, District of Columbia, United States, 20007

Contact: Murugan K Ravindran, MD look4murugan@...

Principal Investigator: N Baraniuk, MD

Sub-Investigator: Hilda Maibach

Sub-Investigator: Vance , MD

Sub-Investigator: . Fraser C , MD

Sub-Investigator: Cristina Di Poto, Ph.D

Sub-Investigator: Habtom Ressom, Ph.D

Sub-Investigator: Pannell, Ph.D

Sub-Investigator: Burbelo, Ph.D

Sponsors and Collaborators

town University

National Institute of Environmental Health Sciences (NIEHS)

University of South Alabama

Investigators

Principal Investigator: N Baraniuk, MD town University Hospital

More Information

Additional Information:

Laboratory Website

Publications:

Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic

Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol.

2005 Dec 1;5:22.

Responsible Party: town University Medical Center ( N Baraniuk MD,

Associate Professor of Medicine )

Study ID Numbers: 2006-481, RO1 ES015382

Study First Received: December 17, 2008

Last Updated: February 1, 2010

ClinicalTrials.gov Identifier: NCT00810329 History of Changes

Health Authority: United States: Federal Government

Keywords provided by town University:

CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS.

Additional relevant MeSH terms:

Gastrointestinal Diseases

Colonic Diseases

Disorders of Environmental Origin

Encephalomyelitis

Fatigue Syndrome, Chronic

Signs and Symptoms

Hypersensitivity

Urologic Diseases

Musculoskeletal Diseases

Neuromuscular Diseases

Irritable Bowel Syndrome

Environmental Illness

Multiple Chemical Sensitivity

Fatigue

Immune System Diseases

Myofascial Pain Syndromes

Fibromyalgia

Urinary Bladder Diseases

Nervous System Diseases

Cystitis

Central Nervous System Diseases

Rheumatic Diseases

Intestinal Diseases

Virus Diseases

Cystitis, Interstitial

Muscular Diseases

Digestive System Diseases

Colonic Diseases, Functional

ClinicalTrials.gov processed this record on April 14, 2010

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[Guest guest]

This is very interesting and encouraging to know that people are studying this.

I guess all those doctors who told me that it was all in my head, were right in

a way. :-)

Chris

> Increased cerebrospinal fluid pressure (pressure that helps the cerebrospinal

fluid to move around the brain and the spinal cord), may be related with certain

symptoms like headache, sleep problems, light headedness, increased pain,

excessive tiredness (fatigue) even with minimal work and memory problems.

>