Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

Fibromyalgia Clinical Trial

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.

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Cystitis, Interstitial
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Gulf War Illness
• Interstitial Cystitis
• Irritable Bowel Syndrome
• Multiple Chemical Sensitivity
• Syndrome

• NCT number: NCT00810329
• Study type: Observational
• Source: Georgetown University
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Completion date: April 2011