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Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT00810329
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : February 25, 2014
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
University of South Alabama
Information provided by (Responsible Party):
James Baraniuk, MD, Georgetown University

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 18, 2008
Last Update Posted Date February 25, 2014
Study Start Date July 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00810329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 8, 2010)
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 ]
Original Secondary Outcome Measures
 (submitted: December 17, 2008)
Blood pressure differences in response to exercise, blood tests, 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
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.
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cheek swabs, on the right and left inner cheek. Others:Cerebrospinal fluid samples,Blood samples Urine samples.
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.
Condition
  • Chronic Fatigue Syndrome
  • Fibromyalgia
  • Gulf War Illness
  • Multiple Chemical Sensitivity
  • Interstitial Cystitis
  • Irritable Bowel Syndrome
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2014)
160
Original Estimated Enrollment
 (submitted: December 17, 2008)
150
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00810329
Other Study ID Numbers 2006-481
R01ES015382 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James Baraniuk, MD, Georgetown University
Study Sponsor Georgetown University
Collaborators
  • National Institute of Environmental Health Sciences (NIEHS)
  • University of South Alabama
Investigators
Principal Investigator: James N Baraniuk, MD Georgetown University Hospital
PRS Account Georgetown University
Verification Date February 2014