Clinical Trial Recruiting: Testing Spinal Fluid in ME/CFS Patients

Georgetown University and the National Institute of Environmental Health Sciencesare currently recruiting study participants for a clinical trial for ME/CFS and similar disorders. The purpose of this clinical trial 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.

Description of Clinical Trial:

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.

Eligibility Requirements:

• 21 – 65 years old
• Men & women

Inclusion Criteria:

• Participants must have one of the following disorders: ME/CFS, Fibromyalgia, Interstitial Cystitis, Gulf War Syndrome, IBS, MCS.

Exclusion Criteria:

• You do not want a lumbar puncture performed.
• You have a severe physical impairment where a lumbar puncture will not be possible.
• 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 and/or suicidal thoughts/tendencies.
• You are mentally retarded and do not understand what you are cosenting to.
• You are in jail.
• You are pregnant.
• You smoke more than five cigarettes per day.
• 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 narcotic or other illegal drugs for meds for longer than 3 months.
• You test positive for HIV, have abnormal liver or kidney tests.
• You are participating only to receive payment as part of the study group.

Contact:

• Murugan K Ravindran, MD at 202-687-8231
  Emails: cfsresearch@georgetown.edu, look4murugan@gmail.com, mkr33@georgetown.edu

Source: ClinicalTrials.gov identifier: NCT00810329