Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

NCT00810329 | Completed DMC

• 2 other identifiers: 2006-481R01ES015382
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 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. 3.Assessment of Autonomic Nervous system function (Sympathetic nervous system)between the CFS and HC.
4. 4.Perform Lung Function Testing or pulmonary function test to estimate the lung capacities and score shortness of breath while performing breathing maneuvers.
5. 5.Dolorimetry (18 tender point test) for assessment of pain threshold.
6. 6.Capsaicin skin test
7. 7.Allergy skin test

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.

Outcome Measures

Primary Outcomes (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.

  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.

  3- 4 years

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Chronic Fatigue Syndrome
• Fibromyalgia
• Gulf War Illness
• Multiple Chemical Sensitivity
• Irritable Bowel Syndrome
• Interstitial Cystitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• University of South Alabama: collaborator

Study Sites (1)

Georgetown University Hospital, 3800 Reservoir Rd NW

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (2)

• 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.

  PMID: 16321154 BACKGROUND

• Ravindran 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.

  PMID: 21375763 DERIVED

Related Links

• Laboratory Website

Biospecimen

Retention: SAMPLES WITH DNA

Cheek swabs, on the right and left inner cheek. Others:Cerebrospinal fluid samples,Blood samples Urine samples.

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fibromyalgia; Multiple Chemical Sensitivity; Cystitis, Interstitial; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rheumatic Diseases; Environmental Illness; Hypersensitivity; Immune System Diseases; Disorders of Environmental Origin; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• James N Baraniuk, MD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: July 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

US (1)