The objective of this research study is to look in-depth at the clinical and biological characteristics of ME/CFS. Participants with ME/CFS are inpatients at the clinical center at NIH for approximately two weeks on their first visit and another two weeks if they return for the second round of the study.
There will be a total of 40 people with ME/CFS, 40 healthy controls, and 20 people with successfully treated Lyme disease in the study. The study is open to international participants.
Participants must meet the following qualifications:
– Sudden onset after an infection
– Meet the Canadian Consensus Criteria and Fukuda Criteria
– Be between the ages of 18 and 60
– Severe symptoms that started between six months and five years ago
– Be able to participate in all of the tests listed at https://mecfs.ctss.nih.gov/, including a one-day exercise test
The study is run out of the Clinical Center at NIH by Dr Nath, intramural clinical director of the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health. Scientists at NIH from ten institutes are working on different aspects of the protocol.
How to Participate:
The study looks at a wide range of symptoms and potential co-existing disorders including POTS, PEM, cognitive problems, potential mitochondrial issues, and muscle disorders. There are also studies into genetics and gene expression. The study website at https://mecfs.ctss.nih.gov/ includes details on tests that will be done throughout the study.
After your first visit, an adjudication panel of expert clinicians will review your case, including written notes and test results, and confirm that you meet the Canadian Consensus Criteria and Fukuda Criteria and don’t have any disqualifying co-existing conditions. If all of the clinicians believe that you meet the relevant criteria, then you will be invited back for a second visit that will include more tests.
The expert clinicians are:
- Anthony Komaroff
- Daniel Peterson
- Lucinda Bateman
- Andreas Kogelnik
- Benjamin Natelson
Dr Nath is also on the review panel.
NBC News did an article on the study at https://www.nbcnews.com/health/health-news/nih-study-takes-deepest-dive-yet-baffling-condition-n754271
NIH Clinical Center, Bethesda, MD, USA
NIH will cover the cost of a flight from anywhere in the US for US participants and a caretaker, along with providing a hotel room for the caretaker. International participants are welcome but will have to arrange their own travel to NIH in Bethesda, MD.
You will receive $560 for completing the first visit and an additional $50 for completing cytapheresis. You will receive $1015 for completing the second visit, including the exercise test. You will receive an additional $100 for getting an optional skin biopsy done and $250 for getting an optional muscle biopsy done.