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NIH still needs patients

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I communicated with Angelique.. you also must have proof that you had an infection just prior to developing ME. I feel this is a tough one as many people may have had infections but have no blood test proof from immediately before. Many infections do not show up specifically on testing. I think it’s unfortunate they’re requiring this.
 
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I communicated with Angelique.. you also must have proof that you had an infection just prior to developing ME. I feel this is a tough one as many people may have had infections but have no blood test proof from immediately before. Many infections do not show up specifically on testing. I think it’s unfortunate they’re requiring this.
Agreed. Some are probably like me.

The doctors assumed it was mono, but the blood tests came up negative. In my case, symptoms were very similar to acute flaccid myelitis, which is likely caused by Enterovirus 68.

However, I have no "proof", other than the doctors said they thought it was a viral infection/viral myocarditis from a virus they couldn't identify.
 

viggster

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I communicated with Angelique.. you also must have proof that you had an infection just prior to developing ME. I feel this is a tough one as many people may have had infections but have no blood test proof from immediately before. Many infections do not show up specifically on testing. I think it’s unfortunate they’re requiring this.
I hope she explained that by "proof" they will take things like a documented visit to a doc who records a fever. That's what I had and they accepted it. I did not have any bloodwork that indicated an infection for my sudden onset.
 
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I hope she explained that by "proof" they will take things like a documented visit to a doc who records a fever. That's what I had and they accepted it. I did not have any bloodwork that indicated an infection for my sudden onset.
That sounds more reasonable. Good to hear.
 
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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


Hi Brian,

My name is Sarah. I recently applied to the NIH study this past month. I got ME 4 years ago, my last year of Medical school. My Life story pretty much fits ME criteria perfectly. I was a 2 sport collegiate athlete who went to school for 8 years and now I can not work after all my training nor do mild exercise without debilitating symptoms afterward or a relapse for days. On top of post exertional fatigue, I have all the classic symptoms presented by the ICC yet it seems like NIH recruiters are trying to find things to exclude me and making it extremely difficult to get in.

I do not understand who gets in if I am having this much trouble. I only got the diagnosis in the permutable time because of my medical knowledge base allowing me to to look further into the pathophysiology of my personal symptoms. My school was affiliated with Harvard so we had the same professors. I started medical school in 2011 and we did not learn anything about ME! If I did not learn about it in 2011 at what is considered the highest ranked medical school in the world, I would assume it is not in the curriculum for medical providers in classes prior or at other medical schools.

Then there is the problem of documentation. Just like they said in the movie unrest, we have to be careful what we say. I always under simplified my symptoms and tried to limit to the worst one or two at each time of the visit because of fear of being looked at crazy. The misknowlege and misinformation about ME makes provieders become biased towards psych if listed all to the severity without lab test indicating a problem!. I do not understand how they are getting people in the study who are not self diagnosed within five years and with perfect documentation? There has to be some analytic thinking to determine because it does not seem fair. Personally, I refused to go to Doctor after Doctor because I knew they did not know: I knew they did not learn about this and I did not want to be labeled psych. I was biased into knowing what Doctors thought and wrote without the patient knowing because Of being on the other side. How did people get accurate documentation explaining everything without being labeled psych? I tried to minimize my symptoms and triggers (I would say only occurs, or omit a lot) because I did not want to be considered crazy when I went to specialist. I would try to target the symptoms the specialist concentrated on as well. I probably did try to minimize more than most but am still curious how people in the study got accurate documentation in limited time of appointments every time without being labeled psych?

My biggest issue was documentation by my Primary care. He is old school and documented everything in the HPI (History of present illness) and left the ROS (review of systems) as is. When the ROS is not filled out, it automatically states denies everything by system like denies fatigue ect..... even if he put fatigue in the HPI. It is very clear that he just did not fill it out and it was not that I denied it. I did end up going to my primary care to talk about this and he is in the process of trying to add addendum to the notes. I also was able to get some documentation from specialist I have gone to so hopefully all this extra documentation if looked at together will end up working. I am fearful they will nitpit the fact that I did not show proof of all symptoms at every visit instead of viewing all the documentation and my personal story as a whole still though? This does not affect me as much because fatigue is documented on every other note, but I am also concerned they value fatigue more than any other symptom? It seems like people can easily get in if they consistently have fatigue on documentation despite the importance of other symptoms.

I am in complete despair at this point. I do know some treatments that could help me but pretty much refuse to try anything that would inhibit clear accurate results of test like the ones at NIH. My personality and background will not let me do anything that may sway results without knowing. I know what my test would look like but can not get test like that anywhere else. I need to know! hahah. I need my suffering to have a purpose as well. Being part of a research like this where my results could help provide knowledge for others is so important to me.


I just got nominated to be on the board for CFSAC as a voting member to meet with congress to provide advice and recommendations for the ME community. I would appreciate the knowledge about this stuff for the purpose of this position as well.


I am not bashing or disagreeing with NIH's method of inclusion just confused, curious, and frustrated considering the circumstances. I know you may not have answers to some of these questions but Any questions you could answer or advice you can give would be greatly appreciated. I really want to get in.
 

Dakota15

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@viggster - I just wanted to bump this thread - I believe the NIH is still recruiting for this study, yes?

I believe this was reported after the Teleconference Call with the NIH last Wednesday (7/18) and thought it would be a good idea to bump this thread.

If I'm wrong please feel free to correct.
 

Tom Kindlon

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@Tom Kindlon Tom do you recall how many patients are still needed for recruiting at this time? Or was no number / figure disclosed on the call.
I think maybe only four or five patients have done the second stage.
Not all patients who do the first stage are eligible for the second stage.
And lots of people who apply are not proving eligible.
The bottom line based on what they have done so far is that they need hundreds of patients to apply to have enough patients it seems.
 

*GG*

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I will have to look into this. Is this study details available in PDF or the like so I can print out and look more closely?!

So what is the compensation? Where do I have to travel to? I live in Northern, NH. these details matter!

GG
 

Dakota15

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I didn't track down a PDF, but again here's the quick link for reference:

https://mecfs.ctss.nih.gov/index.html

Per Brian's post,

"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."

Lastly, the NIH is located in Bethesda, Maryland.
 

Dakota15

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I know of a couple others whom just applied to this in the last few days after sharing with (myself included did not know of this opportunity), definitely want to make sure any and all of those who want to further research see this - if eligible it's a great platform to give research the chance to progress our illness.
 

Tom Kindlon

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RYO

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I completed 2nd phase of NIH intramural study in early 2018. The inclusion criteria is listed at - https://clinicaltrials.gov/ct2/show/NCT02669212?recrs=ab&cond=ME/CFS&rank=3

Angelique Gavin is very helping in setting up travel arrangements for enrollee and spouse. They pay for all travel expenses in addition to stipend for participating in the study.

I would be happy to answer any questions about specific aspects of intramural study.
 

*GG*

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I completed 2nd phase of NIH intramural study in early 2018. The inclusion criteria is listed at - https://clinicaltrials.gov/ct2/show/NCT02669212?recrs=ab&cond=ME/CFS&rank=3

Angelique Gavin is very helping in setting up travel arrangements for enrollee and spouse. They pay for all travel expenses in addition to stipend for participating in the study.

I would be happy to answer any questions about specific aspects of intramural study.
Can you give more details on bolded part. thanks!

GG
 

RYO

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Can you give more details on bolded part. thanks!

GG
They pay for airfare, taxi from airport and meals incurred during travel. If you are within driving distance to Bethesda, they will pay by mileage. This is for both the enrollee and spouse (or one family member). Basically, if you are flying they purchase the airline tickets for you through travel agency they use. They arrange for cab to pick you up from the airport.

I think amount of stipend was mentioned in another post. They added muscle biopsy after I completed phase I of study. If I remember correctly, they provide an additional $200 for undergoing muscle biopsy.