Editor’s note: This is a clarification on the NIH’s earlier, accidental release of the intramural study protocol, which listed the Reeves definition as the sole definition of the new study. Robert and Courtney’s summary of their conversation has been confirmed by multiple sources within the patient community, including #MEAction.
Robert and I had a well-timed chance to discuss with NINDS some questions about the protocol that was posted this weekend for the NIH Clinical Center study. There will be additional information posted on a website for patients and the community which may take a week to be live, they said.
We asked questions about the criteria for enrollment, reference to Reeves criteria in the protocol, role of ME/CFS experts and the choice of control groups. According to the principal investigator of the study:
- Enrollees will meet all definitions for ME/CFS, including Canadian Consensus Criteria, IOM, Fukuda and Reeves, in addition to post-infectious onset.
- Post-exertional malaise (PEM) is a criteria, and will be specifically studied with extensive testing before and after exercise challenge.
- The SF-36 criteria to measure functional impairment stated in the protocol online is inverted mistakenly. “Greater than” is meant to be “less than” in the SF-36 measures.
- Dr. Ian Lipkin of Columbia University’s Center for Infection and Immunity has been advising the investigators on the study design and protocol.
- Expert clinicians will be used in patient selection.
- Control groups: Asymptomatic Lyme was chosen to contrast post-infectious ME/CFS patients to patients who recovered from an infection. Functional Movement Disorder was chosen to contrast post-infectious ME/CFS patients with a very well-studied group of patients with clear psychological illness with neurological presentation.
- They seek to have 40 PI-ME/CFS patients, and they will study them longitudinally, hoping to learn how and whether the disease changes over time.
- Testing will be extensive.
We are very excited to know that the NIH intramural study is moving forward, and that it will deeply study patients with infectious onset against a battery of biological tests. We are reassured by these answers, and eager to have this kind of data to move our disease toward discovery.
— Courtney and Robert Miller