NIH Clinical Center Trial First Step To Identifying Treatments For ME/CFS

Discussion in 'ME/CFS and FM News' started by Cort, Feb 16, 2016.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    A Short Report From Courtney Miller on Dr. Nath's CDC Grand Rounds Presentation on the NIH's Clinical Trial

    (Full blog later)

    "We believe this work will allow therapies to be identified" Dr. Avindra Nath

    Stringent Diagnostic Criteria: The study will draw its patients from ME/CFS experts and have stringent diagnostic criteria.
    • enrollment criteria include Canadian Consensus Criteria, PEM
    • infectious onset is required
    • enroll from expert clinical sites in CDC multi-site study (those include: Peterson, Klimas, Lapp, Bateman, Podell, Kogelnik, Natelson)
    Nath believes that an infection alters immune functioning which then whacks the brain.
    • His focus will be on immune dysfunction"
    • The hypothesis of study is that post-infectious ME/CFS is triggered by viral infection which results in immune mediated brain dysfunction
    • He believes that viral onset patients are likely to have similar immune profile
    Large study will examine a huge number of immune factors and proteins
    • It will analyze 1500 analytes (cytokines/chemokines) and 2500 proteins)
    • They hope to identify the cell or cells that are dysfunctional and causing ME/CFS and explore them deeply
    • They will also study neurological changes before and after exercise and hope to develop an animal model
    Post Exertional Malaise: They will investigate the physiology of fatigue using the exercise studies and
    • functional MRI's
    • Metabolic studies
    • transcranial magnetic stimulation and
    • autonomic nervous system functioning
    End Game: The last phase of the projected three phase study will use an immunomodulating drug to target the immune dysfunction found in the earlier phase of the study
    • 3 Phase study: Ph 1 phenotype, Ph 2 validate biomarkers, Ph 3 intervention study with immunomodulatory agent targeting biomarkers
    Plus be covered in a blog
    Last edited: Feb 16, 2016
    Sheryll, ScottTriGuy, Seanko and 3 others like this.
  2. Hello!

    Hello! Well-Known Member

    I wonder how long it will take the to recruit subjects, collect and analyze the data, and then release the findings?
    Neunistiva likes this.
  3. Seanko

    Seanko Well-Known Member

    Last edited: Feb 18, 2016
  4. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    That was fast! :) That reminds me of the XMRV days when Dr. Mikovits would give a talk and an army of ME/CFS patients would bang out a transcript within days.

  5. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    As I remember the study is going to start pretty quickly - I thought it was supposed to start within a month or two. The rest of it - who knows. I expect that the findings will come out in a series of papers - one on immunology, one on the exercise findings - depending on how quickly each expert gets through with them.

    It usually seems to take a lot of time.
  6. Hello!

    Hello! Well-Known Member

  7. Hello!

    Hello! Well-Known Member

    My questions didn't come through on my last post, probably my fault.

    I was wondering if the CDC waits to publish finding from research they do in house? Do they wait for journal acceptance and publication, or do they publish it themselves?
    Merry likes this.
  8. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    It all goes through a journal
    Merry and Hello! like this.
  9. Sarah R.

    Sarah R. Active Member

    Thanks for the link!
    Hello! likes this.