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Posted at the request of Dr. Peter Rowe - study recruitment

Discussion in 'Active Clinical Studies' started by Denise, Sep 18, 2013.

  1. Denise

    Denise Senior Member

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    Sent on behalf of Dr. Rowe, for patients close enough to travel to/from Baltimore

    “We are actively recruiting patients with Chronic Fatigue Syndrome who might be interested in participating in a study we have been conducting. We are in our final 2 months of the study.

    The study examines ways in which the nervous system might get sensitized in those with CFS, and involves a single visit to the Johns Hopkins Bayview campus for a half day, along with a follow-up phone call about symptoms the next day. Participants complete several questionnaires about baseline symptoms (about 45 min), have measurements of range of motion of the limbs, pain threshold measurements, as well as a Holter monitor [clarification from Denise – the Holter monitor is used only during the on-site portion of the study] to look at heart rate variability.

    Individuals are then randomized to a neuromuscular strain for 15 minutes (we hold their leg elevated at a point where they feel stretch but not pain) or a more modest leg strain. People can remain on their usual medications, but we want them to skip short-acting morning medications like midodrine, atenolol, stimulants, etc., on the day of the test. We are mainly looking for those with CFS between the ages of 18-50 years, with at least moderate symptoms consistent with CFS (no “cured” CFS patients). People with both CFS and fibromyalgia are eligible, but they have to meet the CFS criteria. The study procedures have been well tolerated. Participants are not likely to gain anything individually from participating, but we do compensate them $100 for their time.

    Anyone who is interested or would like to find out more can e-mail Malini Moni, the study research assistant. Her e-mail is mmoni2@jhmi.edu.

    Peter C. Rowe, MD”



    TAKE PART IN A RESEARCH STUDY ON CHRONIC FATIGUE SYNDROME

    We are recruiting individuals to participate in a research study to learn if there are any differences in the way people withchronic fatigue syndrome respond to a particular type of physical examination.

    WHO: Individuals, age 16-50, with chronic fatigue syndrome

    WHAT: A single 2-hour study visit and a follow-up phone call on the day after the study visit. You will complete some questionnaires and brief physical exams while having your blood pressure and heart rate measured.

    WHERE: The Johns Hopkins Bayview Medical Center

    BENEFIT/RISK: There are no direct medical benefits or significant risks for participating in this study.

    COMPENSATION: $100

    CONTACT: Malini Moni: (410) 550-9826
    Mmoni2@jhmi.edu
    Peter C. Rowe, MD, Principal Investigator (NA_00042806)
    Research funded by the CFIDS Association of America
    beaker, Esther12, aimossy and 2 others like this.
  2. Sasha

    Sasha Fine, thank you

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    Man, that's tiny type! I've cut and pasted it into Notepad (strips out hidden formatting) and repasted it here (sets it to our default type). Denise - please feel free to cut and paste into your original! Interesting post. :)

    Sent on behalf of Dr. Rowe, for patients close enough to travel to/from Baltimore

    “We are actively recruiting patients with Chronic Fatigue Syndrome who might be interested in participating in a study we have been conducting. We are in our final 2 months of the study.

    The study examines ways in which the nervous system might get sensitized in those with CFS, and involves a single visit to the Johns Hopkins Bayview campus for a half day, along with a follow-up phone call about symptoms the next day. Participants complete several questionnaires about baseline symptoms (about 45 min), have measurements of range of motion of the limbs, pain threshold measurements, as well as a Holter monitor [clarification from Denise – the Holter monitor is used only during the on-site portion of the study] to look at heart rate variability.

    Individuals are then randomized to a neuromuscular strain for 15 minutes (we hold their leg elevated at a point where they feel stretch but not pain) or a more modest leg strain. People can remain on their usual medications, but we want them to skip short-acting morning medications like midodrine, atenolol, stimulants, etc., on the day of the test. We are mainly looking for those with CFS between the ages of 18-50 years, with at least moderate symptoms consistent with CFS (no “cured” CFS patients). People with both CFS and fibromyalgia are eligible, but they have to meet the CFS criteria. The study procedures have been well tolerated. Participants are not likely to gain anything individually from participating, but we do compensate them $100 for their time.

    Anyone who is interested or would like to find out more can e-mail Malini Moni, the study research assistant. Her e-mail is mmoni2@jhmi.edu.

    Peter C. Rowe, MD”



    TAKE PART IN A RESEARCH STUDY ON CHRONIC FATIGUE SYNDROME

    We are recruiting individuals to participate in a research study to learn if there are any differences in the way people withchronic fatigue syndrome respond to a particular type of physical examination.

    WHO: Individuals, age 16-50, with chronic fatigue syndrome

    WHAT: A single 2-hour study visit and a follow-up phone call on the day after the study visit. You will complete some questionnaires and brief physical exams while having your blood pressure and heart rate measured.

    WHERE: The Johns Hopkins Bayview Medical Center

    BENEFIT/RISK: There are no direct medical benefits or significant risks for participating in this study.

    COMPENSATION: $100

    CONTACT: Malini Moni: (410) 550-9826
    Mmoni2@jhmi.edu
    Peter C. Rowe, MD, Principal Investigator (NA_00042806)
    Research funded by the CFIDS Association of America
  3. Denise

    Denise Senior Member

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    Thank you Sasha! (Apologies for the earlier font size.)
    deirdre, beaker and Sasha like this.
  4. Denise

    Denise Senior Member

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    Please note - this study is for people 18-50 years of age!
    deirdre likes this.
  5. Snow Leopard

    Snow Leopard Senior Member

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    While I am all for more science, I'm not at all sure why such limited testing is going to be of use. Secondly, asking to skip medications is a big no-no, patients taking stimulants etc that would confound the trial should be excluded altogether. Short term stopping of such drugs will almost certainly confound results.
    deirdre and snowathlete like this.
  6. beaker

    beaker CFS/ME 1986

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    I have now been sick long enough that I officially no longer qualify for studies based on age.
    That bums me out.
    Little Bluestem likes this.
  7. taniaaust1

    taniaaust1 Senior Member

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    If only patients who werent on meds were able to go into the trials, it would mean only the least sickest would be studied. Less sick may mean far less or even no abnormal results. The sicker the patients are going into the trials, the better.

    Im in a trial at the moment and to be in have to miss my meds for at least a week before the study week (and during the study week too). Its been very tough on me to do this (Im far more exhausted, POTS far worst, far more discomfort etc) but I think its important for some of us to be making sacrifices to make sure there are sicker patients going into the studies esp when ME/CFS is currently being mixed and the results of CFS studies are being put onto ME patients.
    Little Bluestem and peggy-sue like this.
  8. Snow Leopard

    Snow Leopard Senior Member

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    @taniaaust1

    I wasn't suggesting eliminating all meds, but rather meds that are likely to confound results. In those cases, stopping the meds for a day or two is likely to have other consequences and the withdrawal will confound the results anyway.
  9. peggy-sue

    peggy-sue

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    They are only following up one day later, not two or three. :mad:

    edited to add.
    Please see my later post, I have got hold of the wrong end of the stick here, the follow-up does not provide measurements and the study is not looking to either create, or measure PEM.
  10. alex3619

    alex3619 Senior Member

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    [Sarcasm] What has that got to do with CFS? Its not ME after all. [End sarcasm.]

    We need better standards for ME research. I would like to see our lead researchers come up with a guideline for studies. This is needed as much as a good definition.
    peggy-sue likes this.
  11. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    You may like to view a recent study by this researcher while deciding whether to participate.
    NK17, beaker and peggy-sue like this.
  12. Little Bluestem

    Little Bluestem Senescent on the Illinois prairie, USA

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    I think the going off of meds part would have to be determined on a case by case basis. Unfortunately, many of the sickest of us are probably on something that could not be stopped.

  13. Snow Leopard

    Snow Leopard Senior Member

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    All I'm going to say is that this study is in bad need of objective measures of cognitive fatigue (such as various neuropsychological tests) before any real effect can be claimed.
  14. Denise

    Denise Senior Member

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    Hope this helps clarify --- the study Dr. Rowe is conducting is NOT an exercise test.
    The study does require being off of certain meds for the morning of the study. That can certainly be a problem for some patients. I would venture to guess though that most patients have inadvertently missed one dose of meds at some point or another even in the most organized household.

    As part of patient examinations, one thing that is part of every patient exam he conducts is a straight leg test. The patient does not do the lifting – the leg is lifted for them and in this study their leg is held for them for the duration.
    This is not a test involving exercise – it is a test of neuromuscular strain.
    From the experience of some people I know who have taken part in the test, there are negative cognitive ramifications of this.

    The question of why there is only a one-day follow-up --- it has to do with money. There isn't enough money for more follow-up than that.
    I do know that input provided by study participants in days after the follow-up call has been much appreciated and is taken into account.
    deirdre and Marco like this.
  15. peggy-sue

    peggy-sue

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    Would it not be far better to wait until there is funding for second day testing?
    Or if completely restriced - to test on the second day rather than the first?

    (Unless all the subjects have been ill for less than 3 years)

    Otherwise it is an incomplete study - and a waste of time and effort for the patients and staff, and of funding.

    The information will exist on the second day - it's a crime not to collect it...

    eta:

    This is the sort of thing that would have had me working for nothing in my own time to complete.
    It is so frustrating to see science dictated to by filthy lucre.

    editing to add further;:redface:

    I have got hold of the wrong end of the stick here, I did not mean testing on the second day, I meant follow up on the second day. The follow up will not provide measurements, just a report.

    Please see my later post for my apology.
    sorry.
    beaker likes this.
  16. Denise

    Denise Senior Member

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    "Would it not be far better to wait until there is funding for second day testing?
    Or if completely restriced - to test on the second day rather than the first?"

    Given that this is not a CPET test or an exercise test of any sort I am not unclear why you feel two days of a straight leg test would be necessary. This study is not intending to induce Post-exertional collapse.
  17. peggy-sue

    peggy-sue

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    I'm confused now. :redface: It happens a lot, please forgive me.

    You did say;

    "From the experience of some people I know who have taken part in the test, there are negative cognitive ramifications of this."

    PEM or PENE affects all systems - including the brain. I was referring to the after-effects of the testing, not the test itself. you are only following up on their symptoms one day later, not two.

    I did not mean test on the second day - I meant follow-up.:alien:

    But I am now realising this does not give you any measurements - just a subjective report.
    The effort of traveling would be a very major confounding variable, big enough to wipe out any effects seen.


    Please accept my apologies.
    I will edit my previous posts to refer to this one.

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