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View Clinical Trial (Medical Research Study)
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Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome - NCT00810329-20007 (Clinical Trial 260867)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy260867.aspx
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| City: |
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Washington |
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State:
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DC |
| Zip Code: |
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20007 |
| Conditions: |
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Chronic Fatigue Syndrome - Fibromyalgia - Gulf War Illness - Multiple Chemical Sensitivity - Interstitial Cystitis - Irritable Bowel Syndrome |
| Purpose: |
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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
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Georgetown University Hospital, 3800 Reservoir Rd NW
Washington, DC 20007
United States
Primary Contact:
Murugan K Ravindran, MD
Email: look4murugan@gmail.com
Phone: 202-687-8231
Secondary Contact:
Murugan K Ravindran, MBBS
Email: cfsresearch@georgetown.edu, look4murugan@gmail.com, mkr33@georgetown.edu
Phone: 202-687-8231 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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