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Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
This study is currently recruiting participants.
Study NCT00810329 Information provided by Georgetown University
First Received: December 17, 2008 No Changes Posted
Tracking Information
First Received Date ICMJE December 17, 2008
Last Updated Date December 17, 2008
Start Date ICMJE January 2007
Current Primary Outcome Measures ICMJE
(submitted: December 17, 2008) 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. [ Time Frame: 3 - 4 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures ICMJE
(submitted: December 17, 2008) Blood pressure differences in response to exercise, blood tests, questionnaire results and sensory nerve testing to determine the role(s) of altered nerve and brain function in Chronic fatigue syndrome. [ Time Frame: 3- 4 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE Same as current
Descriptive Information
Brief Title ICMJE Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
Official Title ICMJE Study Looking for Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
Brief Summary
The purpose of this study is:
To look for 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 patients, but not in healthy controls. A similar study that the investigators had conducted before,suggests that significant changes in proteins in the cerebrospinal fluid may be due to the fundamental pathology of this disorder.
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.
Detailed 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. Assessment of lung capacity and scoring the shortness of breath as a result of breathing testing also called as the Pulmonary function testing (PFT).
2. Compare the blood pressure and heart rate response before and after hand grip exercise testing.
3. Skin tests like the 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 sensitivity and loud noises could give them headache. We are analysing those group of people and decision have to be made as to which medications would work at best and give them immediate relief from headache in these group of participants.
Study Phase
Study Type ICMJE Observational
Study Design ICMJE Cohort, Prospective
Condition ICMJE
Chronic Fatigue Syndrome
Fibromyalgia
Gulf War Illness
Multiple Chemical Sensitivity
Interstitial Cystitis
Irritable Bowel Syndrome
Intervention ICMJE
Study Arms / Comparison Groups
This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and other conditions like Multiple chemical sensitivity, Irritable bowel syndrome, Interstitial Cystitis, Gulf War Illness.
The healthy control group
Publications * Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 150
Estimated Completion Date April 2010
Estimated Primary Completion Date April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
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.
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.
Gender Both
Ages 21 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ICMJE
Contact: Murugan K Ravindran, MD 202-687-8231 cfsresearch@georgetown.edu, look4murugan@gmail.com, mkr33@georgetown.edu
Location Countries ICMJE United States
Expanded Access Status
Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
This study is currently recruiting participants.
Study NCT00810329 Information provided by Georgetown University
First Received: December 17, 2008 No Changes Posted
Tracking Information
First Received Date ICMJE December 17, 2008
Last Updated Date December 17, 2008
Start Date ICMJE January 2007
Current Primary Outcome Measures ICMJE
(submitted: December 17, 2008) 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. [ Time Frame: 3 - 4 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures ICMJE
(submitted: December 17, 2008) Blood pressure differences in response to exercise, blood tests, questionnaire results and sensory nerve testing to determine the role(s) of altered nerve and brain function in Chronic fatigue syndrome. [ Time Frame: 3- 4 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE Same as current
Descriptive Information
Brief Title ICMJE Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
Official Title ICMJE Study Looking for Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
Brief Summary
The purpose of this study is:
To look for 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 patients, but not in healthy controls. A similar study that the investigators had conducted before,suggests that significant changes in proteins in the cerebrospinal fluid may be due to the fundamental pathology of this disorder.
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.
Detailed 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. Assessment of lung capacity and scoring the shortness of breath as a result of breathing testing also called as the Pulmonary function testing (PFT).
2. Compare the blood pressure and heart rate response before and after hand grip exercise testing.
3. Skin tests like the 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 sensitivity and loud noises could give them headache. We are analysing those group of people and decision have to be made as to which medications would work at best and give them immediate relief from headache in these group of participants.
Study Phase
Study Type ICMJE Observational
Study Design ICMJE Cohort, Prospective
Condition ICMJE
Chronic Fatigue Syndrome
Fibromyalgia
Gulf War Illness
Multiple Chemical Sensitivity
Interstitial Cystitis
Irritable Bowel Syndrome
Intervention ICMJE
Study Arms / Comparison Groups
This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and other conditions like Multiple chemical sensitivity, Irritable bowel syndrome, Interstitial Cystitis, Gulf War Illness.
The healthy control group
Publications * Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 150
Estimated Completion Date April 2010
Estimated Primary Completion Date April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
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.
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.
Gender Both
Ages 21 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ICMJE
Contact: Murugan K Ravindran, MD 202-687-8231 cfsresearch@georgetown.edu, look4murugan@gmail.com, mkr33@georgetown.edu
Location Countries ICMJE United States
Expanded Access Status