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NIH still needs patients

viggster

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Hi - I'm nearing the end of week 2, visit 2 of the NIH study. Thought that I'd reiterate to the community that the study is still recruiting and still needs patients. To volunteer, contact patient coordinator Angelique Gavin (who is lovely): angelique.gavin@nih.gov and (301) 402-0880.

To reiterate the criteria: Patients must have had a sudden-onset illness and be within 5 years of the onset. The study is in all likelihood too intense for severe patients.

Lots of sub-studies have been added over the past year, since the study began, including skin and muscle biopsies and viral discovery in spinal fluid. I just donated 24 milliliters of it today, and two sterile, DNA and RNA-free vials with my "liquid gold" (in one doctor's words) were flash-frozen in liquid nitrogen and whisked away.

Visit one is a deep phenotyping visit: The volunteer is thoroughly assessed and other illnesses are ruled out. A five-doctor panel of outside ME experts then adjudicates the patient's file. If they are judged (unanimously) to have ME by CCC and Fukuda criteria, they are invited back for visit 2. Visit 2 includes a one-day exercise test (on a stationary bike), and five nights in metabolic chamber. They are assessing PEM quite thoroughly. It is fairly intense, and each patient needs to judge whether they can handle it. I am having a tough week but I'm doing a bit better than when I did a two-day exercise test three years ago for insurance purposes. So I'm grateful for that.

Volunteers will have travel paid by NIH and also receive a stipend for each visit. (About $600 for visit 1 and $1000 for visit 2). Each visit takes two weeks. Partners or family members are put up at a lodge on the NIH campus, which is very convenient to the Clinical Center, or at a nearby hotel.

Happy to answer questions on this thread. More details are available at the NIH ME/CFS site here: https://mecfs.ctss.nih.gov/index.html

Brian
 

viggster

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I would love to join in, but I don't qualify for the post viral part. My symptoms didn't start suddenly after a virus.
What a pity
Yes that requirement shrinks the patient pool substantially. Here is the NIH response in their FAQ as to why they're restricting the study to sudden onset cases:

1. Why is the focus of the study on post-infectious ME/CFS patients?
People have symptoms of ME/CFS that arise from many potential causes. Focusing initially on a single potential cause will let the researchers better single out potential biological changes with ME/CFS. These results may then be applicable to the broader ME/CFS community and may be expanded in future research studies.
 
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My limit was 7 mins too when I did cpet for Insurance. Eugh I would join in but I just can’t risk losing function as happened then. They’re not interested in patients who cannot do the exercise test, correct? (As in — could only complete the first inpatient week)
 

viggster

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My limit was 7 mins too when I did cpet for Insurance. Eugh I would join in but I just can’t risk losing function as happened then. They’re not interested in patients who cannot do the exercise test, correct? (As in — could only complete the first inpatient week)
Right, the exercise and PEM studies are integral to the study. So volunteers are signing up for some pain, but to deeply study PEM they need to see it. They do blood draws and interviews at 1 hour, 4 hours, 24, 48 and 72 hours after the exercise, trying to capture the shape over time of whatever happens. Also a lumbar puncture at 48 hours and various brain scans. Three nights in a metabolic chamber self-service as well. It's got to be the most thorough evaluation of PEM ever performed. The PEM studies were heavily influenced by the out-patient focus group, so thanks to the patients who participated in that process. I think it's a really smart study design.
 

ahimsa

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Daisymay

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Many thanks for taking part and to everyone else who is taking part x

Could you please explain what the metabolic chamber bit is about and involves?

And that's interesting, the spinal fluid test is for viruses? Do they also test for other things like cytokines etc?

When do they hope to have finished the trial?
 

viggster

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Many thanks for taking part and to everyone else who is taking part x

Could you please explain what the metabolic chamber bit is about and involves?
Sure. It's a sealed room, a little like a 12' by 12' prison cell. :) Air is blown in (it's noisy) and collectors on the ceiling pull in and then analyze everything the occupant exhales. Calories coming in are counted and controlled. They feed you through a little airlock door. Turns out the analysis of the ratio of exhaled O2 and CO2 gives a lot of information about metabolism: Whether the person is burning more carbs, fat, or protein. Sleeping in there was tough for me because of the noise from the blowers. I tried all kinds of hearing protection and did get some sleep but not enough. I'm happy to be done with it. I was in there about 16 hours a day for four days straight. :eek:

And that's interesting, the spinal fluid test is for viruses? Do they also test for other things like cytokines etc?
The spinal fluid is being examined in a bunch of different ways. One experiment is doing viral discovery - the technology they use can find known and unknown viruses. They are also doing a sophisticated immune analysis of spinal fluid. I don't know much about it but that experiment will examine thousands of proteins in spinal fluid and compare the controls to the patients to look for differences.

When do they hope to have finished the trial?
I'm not sure. At the current pace, I think it will take about four years to finish (they started a year ago). That's too long IMO and I'm sure many patients feel the same. I've talked to some folks here about how they can speed it up. They tried running a healthy control & a patient through the protocol at the same time. It sounded a little hairy but I think they will try that again. The healthy people don't need as much attention so they should be able to make that work. This protocol has about 40 sub-studies drawing on expertise across the whole NIH. So it's not as simple as hiring more people to work on the study. The protocol calls for many different resources - MRI machines, the metabolic chambers, Avi Nath's neuroscience lab, immunology facilities, the rehab facilities (exercise bike), nutritionists, occupational therapists, cognitive testing experts, the patient rooms, etc., that are also being used in thousands of other on-campus NIH studies. So making it all work together is a pretty big task. I'm impressed with how things are going so far, but I've expressed frustration at the pace. I know other patients have too. So we'll see. There's a bit of a trade-off at play here: This is a very in-depth study, which means it's going to take a while. Each patient stays for a total of nearly four weeks across two visits. The controls stay for almost three weeks each.

The first publication out of the study will likely be from the PEM focus group that one person on the study put together. 20 patients did a total of four teleconferences, and their experiences and input shaped the PEM part of the study. Very important work - so thank you to the people who participated. Sounds like that paper is close to publication.

Brian
 
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Daisymay

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Thanks that's all very interesting. I'm really glad you are bringing up the time scale issue, they need to realise how seriously ill so many people are and that time is not on their side, but I appreciate it is a very complex study, but perhaps there is scope to push the whole administrative/publishing side of things to hasten it all along, along with more funding!
 

Tom Kindlon

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Hi @viggster - thanks for answering all those questions!

I hope more patients are found who can join the NIH study.

Just thought I'd share some links.

@Tom Kindlon has tweeted this for those folks on twitter who want to re-tweet and spread the news:


And here's the link to the S4me.info thread for those who are more active on that forum:

https://www.s4me.info/threads/the-nih-study-needs-patients-from-brian-vastag.2980/

I hope this helps :)
Thanks.
If anyone wants to like or share it on Facebook, I posted it here:
https://www.facebook.com/TomKindlon...41828.656049027876559/997184670429658/?type=3
 
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To reiterate the criteria: Patients must have had a sudden-onset illness and be within 5 years of the onset. The study is in all likelihood too intense for severe patients.
Wish I lived closer. Don't think they'd spring for travel from Colorado, would they? Would love to participate. I fit the criteria.

Heartbroken. I'm outside the upper age limit. Really wanted to participate. I hate when such studies use an arbitrary number. Until ME hit, I outworked colleagues 1/2 my age, and could probably still do so for some of them. So here I sit, an onion in a petunia patch....sigh
 
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viggster

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Do you know if you get your test results?
Yes, participants get many results that can be helpful in guiding care: Tons of bloodwork, MRIs, tilt table tests, spinal fluid analysis, others. Patients do not see results classified as research, such as analysis of immune system proteins, for two reasons. First, the samples are being pooled (dumped together) in groups, one for patients, one for controls. So there is no individual analysis. And second, even for research results with individual analysis (such as fMRI) no one will know the clinical significance of those results until all of the analysis is finished.