Chronic Fatigue SyndromeNCT00810329
Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome
An observational study of Chronic Fatigue Syndrome and Fibromyalgia, run by Georgetown University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Fibromyalgia, Gulf War Illness
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions 2. IRB-approved websites and support groups. 3. IRB- approved advertisments 4. Self-referral.
Who may be able to join
- Chronic Fatigue Syndrome
- Fibromyalgia
- Gulf War Illness
- Multiple Chemical Sensitivity
- Irritable Bowel Syndrome
- Interstitial Cystitis
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital, 3800 Reservoir Rd NW
Washington D.C., District of Columbia, 20007
About this study
Official title: Identify Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
The purpose of this study is:
- 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.
- 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.
- Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the CFS and HC.
- Perform Lung Function Testing or pulmonary function test to estimate the lung capacities and score shortness of breath while performing breathing maneuvers.
- Dolorimetry (18 tender point test) for assessment of pain threshold.
- Capsaicin skin test
- Allergy skin test
Read the 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:
- 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.
- 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).
- Skin tests like:
- 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.
- 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.
- 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.
- Conditions
- Chronic Fatigue Syndrome, Fibromyalgia, Gulf War Illness, Multiple Chemical Sensitivity, Interstitial Cystitis, Irritable Bowel Syndrome
- Keywords
- CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS.
- Medical subject headings
- Fatigue Syndrome, Chronic, Fibromyalgia, Multiple Chemical Sensitivity, Cystitis, Interstitial, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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. | |
| 2 | The healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 - 4 years
Secondary outcomes (1)
Blood pressure differences in response to exercise, blood test and cerebrospinal fluid, questionnaire results and sensory nerve testing to determine the role(s) of altered nerve and brain function in Chronic fatigue syndrome.
Measured: 3- 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), University of South Alabama
- Responsible party
- Principal investigator, James Baraniuk, MD, Georgetown University
- Investigators
- James N Baraniuk, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810329
- Sponsor's protocol ID
- 2006-481
- Other IDs
- R01ES015382
- Status last verified
- Feb 2014
- First submitted
- 17 Dec 2008
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1186/1471-2377-5-22.
PubMed 16321154Ravindran MK, Zheng Y, Timbol C, Merck SJ, Baraniuk JN. Migraine headaches in chronic fatigue syndrome (CFS): comparison of two prospective cross-sectional studies. BMC Neurol. 2011 Mar 5;11:30. doi: 10.1186/1471-2377-11-30.
PubMed 21375763
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls.
- ClinicalTrials.gov ID
- NCT00810329
- Acronym / sponsor ID
- 2006-481
- Conditions
- Chronic Fatigue Syndrome, Fibromyalgia, Gulf War Illness, Multiple Chemical Sensitivity, Interstitial Cystitis, Irritable Bowel Syndrome
- Keywords
- CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), University of South Alabama
- Study start
- Jul 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- 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.
- 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.
- Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the CFS and HC.
- Perform Lung Function Testing or pulmonary function test to estimate the lung capacities and score shortness of breath while performing breathing maneuvers.
- Dolorimetry (18 tender point test) for assessment of pain threshold.
- Capsaicin skin test
- Allergy skin test
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:
- 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.
- 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).
- Skin tests like:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –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. |
| 2 | – | –The healthy control group |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions 2. IRB-approved websites and support groups. 3. IRB- approved advertisments 4. Self-referral.
Key inclusion criteria (6 listed)
- Chronic Fatigue Syndrome
- Fibromyalgia
- Gulf War Illness
- Multiple Chemical Sensitivity
- Irritable Bowel Syndrome
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Blood pressure differences in response to exercise, blood test and cerebrospinal fluid, 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Background: PubMed 16321154Baraniuk 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. doi: 10.1186/1471-2377-5-22.
- Derived from this study: PubMed 21375763Ravindran MK, Zheng Y, Timbol C, Merck SJ, Baraniuk JN. Migraine headaches in chronic fatigue syndrome (CFS): comparison of two prospective cross-sectional studies. BMC Neurol. 2011 Mar 5;11:30. doi: 10.1186/1471-2377-11-30.
- Laboratory WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N Baraniuk, MD principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome and Fibromyalgia, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.