Discussion in 'Active Clinical Studies' started by Kati, Dec 9, 2016.
Finished grueling 2 weeks at NIH. I would be glad to answer any questions.
Can you give us an overview of your two weeks?
Did they induce PEM and if so did they take any samples or measurements during PEM?
Yes, @RYO, please, tell us anything and everything!
And thank you for participating!
Phase I has 2 parts. Part I does not include exercise challenge to induce PEM. They plan to use metabolic room, functional MRI and transcranial magnetic stimulation in Part 2 after exercise challenge. I briefly met with dietician in preparation for Part 2. The metabolic room is highly controlled sensitive environment. It would make sense that if ME/CFS patients have mitochondrial dysfunction, the metabolic studies have a good chance of picking up abnormality.
Part I was taking extensive history and physical, lumbar puncture, cytapharesis, tilt table testing, neuro-psych testing, psychiatric screening and complete sleep study with EEG. I also met with 2 occupational therapists. OT tried the quantify how disabling ME/CFS can be.
Overall, the staff at NIH at Bethesda were very professional and caring. The researchers are trying to broaden their understanding of ME/CFS but these are scientists that work on other projects who got called to participate in Dr. Nath's study. I was impressed with Dr. Nath. He seems like a grounded person who is empathic and is highly regarded at the NIH.
They were sensitive to the fact that even the strain of Part I may trigger relapse. It was difficult to stay at the NIH Clinical Center (hospital) for almost 2 weeks. I provided feedback to the research team. They were receptive to ideas for making changes to protocol to make it easier for future participants.
How busy were you? Did they build in rest time for you? Do you feel that they were able to understand what your ME/CFS experience is like? Did they ask insightful questions?
The research team adjusted my original schedule to allow more rest time each day. They learned that even healthy controls were stressed by hospitalization and numerous tests.
They took a lot of time obtaining a narrative of my illness. An occupational therapist performed a "free form" audio recorded interview. It was an opportunity to voice my concerns and explain in my own words how devastating this illness is.
I felt they also did a good job to rule out other conditions. For example, I was pretty certain that I didn't have central or obstructive sleep apnea but it was valuable to completely rule it out.
As previously mentioned by @viggster, the data collected during Part I gets adjudicated by panel of ME/CFS experts before they ask patients to participate in Part 2.
I'm at NIH (day 2) and just learned an interesting tidbit. The nursing institute (National Institute of Nursing Research) has a symptom management team. Well I'm sure just that name makes alarm bells go off for many ME/CFS patients. BUT, the scientist on that team working on the ME study is running our fresh blood through a machine called Seahorse. The machine compares real-time mitochondrial function of two samples - in this case, ME/CFS patient vs age-matched control. The team is also working on cancer + chemo + radiation fatigue, looking for the basis of that and what can be done about it. Already after 3 ME patients here at NIH, they have seen big, big differences in oxygen consumption and mitochondrial function, both 'at rest' and in response to a drug challenge. The researcher was excited to see such a big signal of impaired mitochondria in such a small sample already.
Edit: Here's info on the Seahorse technology. http://www.agilent.com/en-us/products/cell-analysis-(seahorse)/how-seahorse-xf-analyzers-work
Thanks @viggster - always nice to pick up tidbits.
Thank you for the encouraging scoop, @viggster. And thank you for putting yourself through the research wringer. It's a good start, hopeful news, looking forward to hearing what's next.
Thanks,@viggster. I've just looked up Seahorse technology. It looks like it has the potential to be really useful in diagnosing and analysing ME/CFS. Does anyone know whether it's been used before in ME studies?
@Ben Howell do you know whether OMF use it?
Before I left the NIH, I inquired about adding muscle biopsy to study design with the hope of evaluating metabolism/mitochondrial function. They mentioned possibly using Seahorse for this purpose. Do you know if they originally planned to use Seahorse or is this something they added on.
I wonder what the differences are if any in studying mitochondrial function and oxygen consumption in cells from serum vs skeletal muscle tissue.
Thank you for this very interesting update.
Thank you @RYO and @viggster for sharing your experience. Sounds like this study will be a great success, which is a relief. I'm particularly curious about the metabolic chamber. What can it tell us about disease?
I just briefly reviewed how the Seahorse XF works. I wonder if the technology that Ron Davis has been working on to detect metabolic abnormalities in ME/CFS patients uses similar methods. It would be highly note worthy if the data from the Seahorse analysis at NIH support and confirm the work being completed by Ron Davis and his team. @Janet Dafoe (Rose49)
Any idea what kind of cells they're analyzing? And from the page about how it works, it looks like the cells are placed in medium so I assume they're not left in serum. That being the case, it would be odd/interesting if they're still seeing the metabolic issues.
A short video about how the Seahorse tech works:
Thanks for the updates @viggster
Here is a photo with Francis Collins:
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I spoke with researcher at NIH. There may be issues with using stored blood obtained from controls months ago. It sounds like they are trying to iron out the details but since they are in early phase of evaluating study patients, I am hoping this still has a good chance of being included in deep phenotyping.
Today I donated about 10 billion peripheral blood cells for a range of experiments. The coolest of them will reverse some of the blood cells into stem cells, then fast-forward them into neurons to study brain dysfunction. It's a hell of a lot easier than donating brain cells. Avi Nath helped pioneer these brain-in-a-dish experiments, which you can read about here: https://www.ncbi.nlm.nih.gov/pubmed/25650990
The photo shows Ben, an aspiring med student who has been squiring myself and the other ME/CFS study volunteers around the campus. Super nice guy, and he now knows a *lot* about this illness and seems very interested in it. Let's hope he represents the future of the field.
Thanks for sharing @viggster. Best wishes!
Do we know when we should expect results from these studies? Is there a timeframe?
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