Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

Completed

Conditions studied: Chronic Fatigue Syndrome, Fibromyalgia, Gulf War Illness, Multiple Chemical Sensitivity, Interstitial Cystitis, Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT00810329

Run by

Georgetown University

People needed

160

Starts

2007-07-01

Expected to finish

2011-04-01

Last updated by the study team

2014-02-25

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Georgetown University Hospital, 3800 Reservoir Rd NW — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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