Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome (NCT00810329) | Clinical Trial Compass
CompletedNot Applicable
Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
United States160 participantsStarted 2007-07
Plain-language 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
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕
What they're measuring
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.
. 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.