Discussion in 'Fibromyalgia Main Forum' started by gapsych, Feb 1, 2009.

  1. gapsych

    gapsych New Member

    I talked with Dr. R from Georgetown and it turns out I do qualify for the study!! Somehow I interpreted him as saying I did not qualify. I am very excited.

    I most likely will do this in March. I am so scared that I will be unable to travel.

    I know several people on this board have participated. Since the search function is still under the weather, if anyone could give me feedback, it would be much appreciated.

    If I remember correctly someone suggested that residents should not do the spinal tap?

    I am also somewhat concerned about being off the Klonepin for two days with the stress of the travel on top of that. I am going to try to not take it for two days and see what happens. I do not know if just stopping is better since it is only two days or if I go down gradually, the withdrawal symptoms may be prolonged and more exhausting.

    Dr. R is such a compassionate doctor/human being. It is so refreshing to hear how he validates our DD.

    He also said I would most likely go home with most of the test results and after the experiment people will get the results of their DNA study. This must be a change? I hope I did not misunderstand him.

    Thanks in advance for any feedback to get ready for the trip.

  2. gapsych

    gapsych New Member

    Hey thanks. You are soooo smart!!

  3. hensue

    hensue New Member

    Are they still recruiting and I would not want a spinal tap but your Dna testing!!!
    Please keep me posted
  4. gapsych

    gapsych New Member

    This was the preliminary study.I edited the article into paragraphs so it is easier to read. I think they are still recruiting.

    January 11, 2006

    Source: Georgetown University Medical Center Washington, DC -- Researchers at Georgetown University Medical Center have found that chronic fatigue syndrome (CFS) may be rooted in distinct neurological abnormalities that can be medically tested. Although the sample studied was small, this research provides objective, physiological evidence that the controversial disorder can be considered a legitimate medical condition.

    Chronic fatigue syndrome defines a range of illnesses including fibromyalgia and Gulf War syndrome, all of which have fatigue as a major symptom. Even among medical professionals, there is a disagreement about the causes, diagnosis and treatment of CFS because so much about the disorder remains unknown. One reason CFS is difficult to diagnose is because it shares symptoms with many other diseases, including multiple sclerosis and lupus. Even when other illnesses are ruled out and a CFS diagnosis is given, there is not a standardized course of treatment and it’s difficult for doctors to measure patient improvement. Estimates are that two to four times as many women as men are diagnosed with CFS.

    The Georgetown study, published in the December edition of the BMC Neurology Journal, an online publication, reveals that patients diagnosed with CFS and its family of illnesses have a set of proteins in their spinal cord fluid that were not detected in healthy individuals. These proteins might give insight into the causes of CFS and could someday be used as markers to diagnose patients with the disorder.

    "For years, patients with chronic fatigue syndrome have suffered from painful symptoms for which there is no blood test, diagnosable physical condition or any method for doctors to measure improvement," said James Baraniuk, MD, assistant professor of medicine at Georgetown University Medical Center and first author on the study. "Our research provides initial evidence that chronic fatigue syndrome and its family of illnesses may be legitimate, neurological diseases and that at least part of the pathology involves the central nervous system."

    The disorder is characterized by profound fatigue that is not improved by bed rest and that may get worse with physical or mental activity, according to the Centers for Disease Control and Prevention. Persons with CFS usually function at a lower level of activity than they were capable of before the onset of illness, feeling too tired to perform normal activities or easily exhausted with no apparent reason. Patients also report various nonspecific symptoms, including weakness, muscle pain, impaired memory and/or mental concentration, insomnia and post-exertional fatigue lasting more than 24 hours.

    The study looked at 50 individuals suffering from at least two disorders related to CFS, including fibromyalgia and Gulf War syndrome. By examining spinal cord fluid in patients with CFS and in healthy individuals, the researchers found that CFS patients have 16 proteins that healthy individuals do not. Five of these 16 proteins are found in all patients with the illnesses but in none of the controls. The results indicate that those 16 proteins could possibly serve as a "biosignature" for the disease and could someday be used to diagnose CFS.

    "Although this is a small study and more research on the subject is necessary, these results indicate it might be possible to develop a simple laboratory test to diagnose these disorders in the future," Baraniuk said. Other co-authors on the paper include Begona Casado, PhD, and Hilda Maibach, MS, of Georgetown University Medical Center; Daniel J. Clauw, MD, of the University of Michigan; and Lewis K. Pannell, PhD, of the University of South Alabama, Mobile; and Sonja Hess, PhD, of the National Institute of Diabetes and Digestive and Kidney Diseases.

    About Georgetown University Medical Center Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO.)

    [This Message was Edited on 02/01/2009]
  5. labrat

    labrat New Member

    I am glad that you are taking part in this study. I went there last June and did the study. The best part was talking to doctors who believed in CFS and knew something about it. They did give me lots of time to rest after I first arrived there to recover some from the travel. It is interesting what you said about patients getting the DNA results after the study. Please let me know if this is correct and we do get the DNA results. Be sure to pack lightly so you don't have a lot to carry on the way home. They have lovely hospital gowns for you to wear while you're there. Good luck!

  6. gapsych

    gapsych New Member

    Wow, nice night gowns in the hospital? Get out!!

    Are they nice enough to take home. I certainly hope they are not too sexy as I would hate to distract the doctors while getting my spinal tap, LOL!! In my dreams.

    Good suggestions about packing lightly. I tend to over pack.

    Thanks for all the support. I need it to be able to make it to Georgetown. I have already checked the flights and they are not that expensive. I can also leave from the local airport and not have to drive to Chicago. That will make a big difference.

    I am excited, scared but want to do this.

    I wonder how many people have not been able to make it to the study because of this DD?

  7. gapsych

    gapsych New Member

    Hi. They do reimburse you for the plane but you have to pay out of pocket first. However, he said that once I get to the airport, the cab will be paid for. Also if I need to stay in the hospital hotel for a few nights if I crash.

    I think they pay you $500 but do not know if you get all of that if your ticket is less.

    I think the reasoning behind this is that someone could buy a ticket and not show up. Perhaps someone might cancel where you lose a hundred dollars but still can use the ticket.

    But I am not positive about that. The people there are so friendly, so reassuring. They really need people to participate.

    I am a little fuzzy on the details right now as I am very sleepy. But I did want to reply to let you know the few details I can recall right now.

    Maybe some of the other people who have gone can also give you some info. There is someone who responded to my post but am afraid I will lose this if I go back to look.

    I wonder if the hotel has a hot tub or a Jacuzzi in the room. I could ask for that as it really helps my legs. Room service, hmmmm? LOL

    I have been meaning to ask you this but hope I am not being nosey. Do you really have 27 grandchildren or are you 27, and a grandmother. Such a young age to be a grandmother!!!



    I am going to email Dr. R. tomorrow and will ask him if I can give people his email address or if there is another way to sign up. I think I emailed him when the first post came out that they were recruiting. I know I heard from him within a couple of days. We talked for about an hour the first time. I know I keep repeating myself but it is sooo nice to be validated and I am not talking about parking!!

    Sorry I am not only foggy but a bit slap happy!!!
    [This Message was Edited on 02/02/2009]
  8. mezombie

    mezombie Member

    Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome

    This study is currently recruiting participants.
    Verified by Georgetown University, November 2008
    Sponsors and Collaborators: Georgetown University
    National Institute of Environmental Health Sciences (NIEHS)

    Information provided by: Georgetown University
    ClinicalTrials.gov Identifier: NCT00810329

    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.

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

    MedlinePlus related topics: Chronic Fatigue Syndrome Fibromyalgia Interstitial Cystitis
    U.S. FDA Resources
    Study Type: Observational
    Study Design: Cohort, Prospective

    Official Title: 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.

    Further study details as provided by Georgetown University:

    Primary Outcome Measures:
    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 ]

    Secondary Outcome Measures:
    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 ]

    Biospecimen Retention: Samples With DNA

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

    Estimated Enrollment: 150
    Study Start Date: January 2007
    Estimated Study Completion Date: April 2010
    Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

    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

    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.


    Ages Eligible for Study: 21 Years to 65 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: Yes
    Sampling Method: Probability Sample

    Study Population
    Georgetown University Division of Rheumatology, Immunology and Allergy and other Divisions
    IRB-approved websites and support groups.
    IRB- approved advertisments

    Inclusion Criteria:

    Chronic Fatigue Syndrome
    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.

    Contacts and Locations

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00810329

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

    United States, District of Columbia
    Georgetown University Hospital, 3800 Reservoir Rd NW Recruiting
    Washington, District of Columbia, United States, 20007
    Contact: Murugan K Ravindran, MD 202-687-8231 look4murugan@gmail.com
    Principal Investigator: James N Baraniuk, MD
    Sub-Investigator: Hilda Maibach
    Sub-Investigator: Vance Watson, MD
    Sub-Investigator: . Fraser C Henderson, MD
    Sub-Investigator: Cristina Di Poto, Ph.D
    Sub-Investigator: Habtom Ressom, Ph.D
    Sub-Investigator: Lewis Pannell, Ph.D
    Sub-Investigator: Peter Burbelo, Ph.D

    Sponsors and Collaborators
    Georgetown University
    National Institute of Environmental Health Sciences (NIEHS)
    Principal Investigator: James N Baraniuk, MD Georgetown University Hospital

    More Information

    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.

    Responsible Party: Georgetown University Hospital ( James N Baraniuk MD, Associate Professor of Medicine )
    Study ID Numbers: 2006-481, RO1 ES015382
    Study First Received: December 17, 2008
    Last Updated: December 17, 2008
    ClinicalTrials.gov Identifier: NCT00810329 [history]
    Health Authority: United States: Federal Government

    [This Message was Edited on 02/03/2009]
  9. gapsych

    gapsych New Member


    Your post has much more information than mine. How did you find it as this is the type of article I was looking for but only came up with the one I posted.

    I think I see it at the top. Is that correct?


    ETA Granny, my daughter turned 33 today. Yikes!!!!
    [This Message was Edited on 02/03/2009]
  10. SpecialK82

    SpecialK82 New Member

    Congratulations gapsych! I'm so excited for you! It's wonderful to find some caring and compassionate medical professionals. I hope this unlocks another piece of the puzzle for you and also for the rest of us. Thank you to everyone participating.

    I will be looking forward to reading about your visit, and I will be praying for you that you are strong enough to travel.

  11. jasminetee

    jasminetee Member

    That's exciting gapsych. I hope it all goes smoothly for you and I'm looking forward to hearing how it went when you come back.

    Thanks for doing this test to help all of us. :)

  12. bakeman

    bakeman New Member

    thanks for participating!
  13. mezombie

    mezombie Member

    Hi Gap,

    You're welcome.

    The information I posted on this study is on clinicaltrial.gov, a US government site that lists most clinical studies. I've consulted it on several occasions. If you go to the site and search for Chronic Fatigue Syndrome or Myalgic Encephalomyelitis, you can find out about most studies for these conditions.

    Actually, I was lazy when I searched for this info and simply googled Georgetown CFS Study. It turned out to be the second hit. I did know to look for the clinicaltrial.gov URL.

    Anhow, good for you (and all of us!) for participating in this study!

    I know our member Marti_Zavala took part in it and posted quite a bit of information on her experience here. I find the search function here still leaves a lot to be desired, but maybe you can find her posts.

    Take care!

  14. simonedb

    simonedb Member

    I am glad to see this thread, I recently contacted them as well about being in this study and I am pondering it, going to ask my local physician his opinion next week.
    I have slight scoliosis, its not supposed to be super significant but that part did make me wonder, what is it about the puncture that could be bad w/curvature? i think mds would say mine isnt too bad to prevent participation but i am cautious cus people have said a lot of things werent that bad for me over the years but then they were.

    they didnt mention the plane reimburse part thats great.
    good for u gapsych, i think a lot of useful info could come out of it for you.
  15. gapsych

    gapsych New Member

    It sounds like it is a good idea to check with your doctor since you have scoliosis. I had not thought of that.

    Yes you do get reimbursed for the flight but you have to pay for it up front.

    Supposedly, the doctor's there have had a lot of practice giving lumbar punctures and now days you do not usually get a headache. If you do, they have medications right there. They also give you caffeine to prevent the headache.

    It sounds like you have talked to Dr. R.?

    Wouldn't it be weird it you were there at the same time I am?

    Take care.
  16. simonedb

    simonedb Member

    I talked to murugan r., an assistant I believe, maybe phd, nice guy. then he sent me the form, but i havent filled it out yet, i dont know if they would accept me yet if i decide to go for it.
    i heard i might feel better after spinal tap from a participant cus i do get weird pressure headaches and have spinal issues that i feel tie into the cfs, hard to understand it over the years but noticed correlation. some people w/headaches feel temp. better aftersome fluid taken out, makes sense, like ever have a headache so bad that drilling a hole in yr head to relieve pressure sounds good? of course some people get a headache from it like ya said.
    will keep ya posted and vice versa.
    to you, what are the most attractive aspects of doing this?
  17. aftermath

    aftermath New Member

    I participated in this study in the summer of 2008. The staff was absolutley wonderful.

    The one thing that I recommend that you strongly insist on is that a senior attending neuroradiologist perform the lumbar puncture.

    Our patient population is too delicate to be used as a learning expereince for residents and fellows.

    I informed the Georgetown folks that I previously had a traumatic tap before coming to the study. I requested that a senior attending do my tap and was told that this would be complied with.

    When we went down for the study, they swapped doctors and my LP was first attempted by a fellow (read: super resident). Dr. Ravindran tried to put a stop to it but he did not have enough juice to get the job done.

    The fellow attempted the tap and it went BADLY. She quit after about 4 minutes and passed the needle off to a senior attending who hit the tap effortlessly.

    I would suggest doing the study but INSISTING that a senior attending do your LP. Insisting means that you get up and leave if they don't comply.
  18. munch1958

    munch1958 Member

    Are they going to be testing your CSF for other pathogens besides this protein? I don't think I'd undergo a spinal tap just to look for ONE protein that they think may or may not be there.
    If they were going to be testing it for viruses and bacteria then it might be worth the pain, the grueling travel schedule, and the exam by the doctors.

    I underwent a bone marrow biopsy in 2003 and ended up with chronic pain in the spot where they did it. I assumed they'd be testing it for everything especially looking for EBV and mycoplasma which are known to be found with bone marrow cancers. They didn't order any type of pathogen screening on my bone marrow sample which was a HUGE disappointment.

    According to this, they will be doing "tender point" testing. Personally, I think "tender point" testing is a load of baloney. There is no scientific basis for this type of testing. Two doctors performing the test never obtain the same results and some are not even trained properly to apply exactly 4 Kg of pressure. How is the test scientifically valid? Bacteria and viruses like to hang out in the root ganglia of nerve cells which is exactly where the tender points are located. This type of testing is subjective both on the part of the patient and the examiner.

  19. gapsych

    gapsych New Member

    I am glad you responded as I remembered that someone had a problem with the spinal tap.

    I will insist upon having a senior attending do the LP.

    How far away do you live from Georgetown and do you have any travel tips? This is my biggest concern.

    Thanks for the information.

  20. aftermath

    aftermath New Member

    With regard to travel, I chose to drive. It was about 200 miles for me.

    That being said, I am on the more functional end of ME/CFS patients. I manage to work full time, but BARELY. I crawl in to bed the second I get home.

    Although I am probably better off than 80% of the people here, I am probably 20% of what I was before I got sick suddenly during my sophomore year of college over ten years ago.

    Just remember, as great of a person as he is, Dr. Ravindran does not have much power in the hierarchy there. You need to advocate for yourself.

    I told them that I wanted someone very experienced doing the LP, and ended up getting a fellow. I didn't want to insult her, but in 20/20 hindsight, I should have refused the procedure unless they got an attending.

    If I were you, I would make it clear that if a resident or a fellow is involved, (e.g. no attending) that YOU ARE LEAVING.

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