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 range
21 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.