We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00810329
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : February 25, 2014
National Institute of Environmental Health Sciences (NIEHS)
University of South Alabama
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University

Brief Summary:

The purpose of this study is:

  1. 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.
  2. 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.
  3. Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the CFS and HC.
  4. Perform Lung Function Testing or pulmonary function test to estimate the lung capacities and score shortness of breath while performing breathing maneuvers.
  5. Dolorimetry (18 tender point test) for assessment of pain threshold.
  6. Capsaicin skin test
  7. Allergy skin test

Condition or disease
Chronic Fatigue Syndrome Fibromyalgia Gulf War Illness Multiple Chemical Sensitivity Interstitial Cystitis Irritable Bowel Syndrome

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:

  1. 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.
  2. 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).
  3. 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.

  4. 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.
  5. 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 160 participants
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.
Study Start Date : July 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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.
The healthy control group

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Cheek swabs, on the right and left inner cheek. Others:Cerebrospinal fluid samples,Blood samples Urine samples.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions
  2. IRB-approved websites and support groups.
  3. IRB- approved advertisments
  4. Self-referral.

Inclusion Criteria:

  1. Chronic Fatigue Syndrome
  2. Fibromyalgia
  3. Gulf War Illness
  4. Multiple Chemical Sensitivity
  5. Irritable Bowel Syndrome
  6. Interstitial Cystitis

Exclusion Criteria:

  1. You do not want to have a lumbar puncture performed.
  2. 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).
  3. 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.
  4. You have a severe psychiatric illness such as schizophrenia, substance abuse, major depression with previous suicidal attempts, gestures or ideas about committing suicide.
  5. 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
  6. You are in jail or prison.
  7. You are pregnant.
  8. 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.
  9. 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.
  10. You have used narcotics or other illegal medications for more than 3 months. These will be discussed with Dr. Baraniuk.
  11. You have a positive HIV test, or blood, liver or kidney tests that are abnormal.
  12. You are participating only so you can be paid for taking part in this spinal tap study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810329

Layout table for location information
United States, District of Columbia
Georgetown University Hospital, 3800 Reservoir Rd NW
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Institute of Environmental Health Sciences (NIEHS)
University of South Alabama
Layout table for investigator information
Principal Investigator: James N Baraniuk, MD Georgetown University Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT00810329    
Other Study ID Numbers: 2006-481
R01ES015382 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Keywords provided by James Baraniuk, MD, Georgetown University:
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Irritable Bowel Syndrome
Cystitis, Interstitial
Multiple Chemical Sensitivity
Pathologic Processes
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Neuroinflammatory Diseases