Proteomics in CFS

Proteomics in CFS Study Participant Login

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Introduction

We invite you to take part in a research study. The study is called Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome (IRB Protocol #2006-481). Please take your time to make your decision. Discuss it with your family and friends. It is important that you read and understand several general principles that apply to all who take part in our studies:

1. a.Taking part in the study is entirely voluntary;
   

2. b.Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained from your participation that will benefit others;
   

3. c.You may withdraw from the study at any time without any of the benefits you would have received being limited or taken away.
   

The nature of the study, the benefits, risks, discomforts and other information about the study are discussed below. Any new information discovered, at any time during the research which might affect your decision to participate or remain in the study will be provided to you. You are urged to ask any questions you have about this study with the staff members who explain it to you. The investigator (person in charge of this research study) is James N. Baraniuk, MD. The research is being sponsored by the National Institute of Environmental and Health Sciences (NIEHS), a part of the National Institutes of Health (NIH). The NIEHS is called the sponsor and the Georgetown University, is being

paid by the NIEHS through grant number RO1 ES015382 to conduct this study with James N. Baraniuk, MD, as the primary investigator.

Why is the study being done?

You are being invited to participate in this study to help Dr. Baraniuk discover the cause(s) of Chronic Fatigue Syndrome.

You are being invited to participate by having a spinal tap and other studies.

A spinal tap is also called a lumbar puncture (LP). The lumbar punctures will be performed under 2 sets of circumstances.

You may have your lumbar puncture performed in the Department of Interventional Neuroradiology. You will be on your stomach. An X-ray (fluoroscopy) will be used to direct the needle between the bones in your lower back for the lumbar puncture.

Second, Dr. Spevak from the Pain Clinic may come to the General Clinical Research Center and perform the lumbar puncture in your bed. You curl up on your left side, or sit up and lean forward as instructed.

The purpose of the lumbar puncture is to obtain a sample of the fluid (cerebrospinal fluid; CSF) that flows around your brain and down your spinal column. Dr. Baraniuk will compare the proteins in the cerebrospinal fluid from Chronic Fatigue Syndrome subjects to samples from volunteers who do not have this syndrome. Differences in the patterns of proteins will help in discovering the cause(s) of Chronic Fatigue Syndrome. This will lead to new treatments for this poorly understood, but often debilitating disorder.

You may NOT participate in this study if any of the following apply to you:

1. 1.You do not want to have a lumbar puncture performed.
   

2. 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. 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. 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. 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. 6.You are in jail or prison.
   

7. 7.You are pregnant.
   

8. 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. 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. 10. You have used narcotics or other illegal medications for more than 3 months. These will be discussed with Dr. Baraniuk.
    

11. 11. You have a positive HIV test, or blood, liver or kidney tests that are abnormal.
    

12. 12. You are participating only so you can be paid for taking part in this spinal tap study.
    

Purpose: The purpose of this study is to have a lumbar puncture.

The cerebrospinal fluid from around the brain will be compared between volunteers with and without Chronic Fatigue Syndrome. Differences in the patterns of the proteins in the fluid will provide clues to the cause(s) of Chronic Fatigue Syndrome. These differences will be used to develop new diagnostic tests and logical treatments. This is an observational study because the natural history and mechanisms of disease will be examined.

This research is being done because we do not understand what goes wrong to cause Chronic Fatigue Syndrome. Dr. Baraniuk has completed a previous study of lumbar punctures and cerebrospinal fluid analysis. That study offered exciting new clues for understanding the mystery of Chronic Fatigue Syndrome. It is now necessary to test additional subjects with and without Chronic Fatigue Syndrome to gain more information about these significant differences in the cerebrospinal fluid proteins.

Chronic Fatigue Syndrome affects 2% of the population, and can persist for years. People who have been very active can become disabled because of chronic fatigue and other problems. There are no diagnostic tests or effective treatments. However, Dr. Baraniuk’s first study suggests that significant changes in proteins in the cerebrospinal fluid may be due to the fundamental pathology of this disorder.

More information about Chronic Fatigue Syndrome is available from our study coordinator and on the internet through our website http://www9. georgetown. edu/faculty/baraniuj/Site/Welcome. html as well as the Center for Disease Control: http://www. cdc. gov/cfs/

If you are interested in participating in our research, please contact:

1) Email: gwiresearch@georgetown. edu

2) Email: cfsresearch@georgetown. edu

3) Phone: 202-687-8231