NIH still needs patients

[*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.

Ok thanks for the info, would be nice if all the info was in 1 place. Like this flyer I have attached!

GG

 

[JaimeS]

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

Same.

 

[Dakota15]

@RYO - appreciate your willingness to help answer any questions!

I do have a few questions....if you'd prefer to have them over PM let me know and we can go that route.

1) How did you feel overall about the experience in regard to the amount of participation that was entailed? I know it is very thorough and asks a lot - were you able to leave the experience not feeling that much worse off?

2) How was sleeping in the metabolic chamber (if I read that right)?

Thanks again

 

[RYO]

@RYO - appreciate your willingness to help answer any questions!

I do have a few questions....if you'd prefer to have them over PM let me know and we can go that route.

1) How did you feel overall about the experience in regard to the amount of participation that was entailed? I know it is very thorough and asks a lot - were you able to leave the experience not feeling that much worse off?

2) How was sleeping in the metabolic chamber (if I read that right)?

Thanks again

I was considered as a moderate to severe ME/CFS patient. Both phases of the study were physically and mentally taxing for me especially the second phase. It took me months to recover. Other factors may also play a role in how someone reacts to the demands of participating in NIH study. My wife was very supportive. Prolonged stays in a hospital setting may be more stressful to some than others. Overall, I felt the nurses, doctors and staff members were accommodating.

The metabolic chamber is roughly a 10 x 10 room with a window, bed and toilet. During phase 2 of study I spent 3 to 4 nights sleeping in the chamber. The toughest part for me was trying to sleep with the EEG cap and heart monitor. It was pretty uncomfortable. It was fairly quiet in the chamber with a faint whirl of white noise from the ventilation system. You feel like "the boy in the bubble". They pass you your meals through an air lock system.

In general, I knew going in that participating in this study was going to throw me into significant PEM. But as with other aspects of my limited life, you make sacrifices. I have missed a lot of my children's school and sports events but sometimes you do what you have to do and suffer the consequences.

It would be difficult to tailor the NIH phases for each individual because it's already taking a long time to complete this study. They are trying to squeeze as many tests as they can without completely wiping you out in the process.

 

[deboruth]

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.

SARAH, please note that CFSAC has no role involving Congress. CFSAC exists to report to/advise the Secretary of Department of Health and Human Services. It is one among a number of such advisory committees. Thus, it is part of the Executive Branch, not the legislative. People who have served on CFSAC have found that their opinions are rarely sought after or acted upon by HHS, let alone by Congress. If you seriously wish to impart information to Congress the direct route would be to start by cultivating the health aides to your representative and Senators. Maybe they will take a teeny bit more note if you are on CFSAC, but they would take lots more note if you could somehow deliver votes and campaign finance. Otherwise you'll have to rely on saying something persuasive.
I have had ME for 29 years now, and also happen to be well acquainted with the American political system and its participants from a variety of perspectives.
Let me offer you some valuable advice; if you have access to treatments that will make you healthier, you are nuts not to undertake them. Don't worry about queering the pitch for the NIH study or other studies. Getting into the NIH study is not an accomplishment or an entrée to much that is valuable, like getting into Harvard or Stanford or about 1,000 other schools, colleges, universities, institutes, centers, libraries and sports competitions. Nor will it be as enjoyable, nor provide durable credentials. I got into Harvard many years ago. Some of the nicest people I have ever met were people I met there. I still value many as friends. I learned a great deal, and had my eyes opened to much that is important, beautiful, or otherwise worth knowing about. The libraries are fabulous. Some of the buildings are world class architecture, and many of the settings are lovely.
None of this will be true of getting into the NIH trial. Nor is it anything like cancer trials that benefit participants via access to treatments. You will get a free trip to Washington DC and room and board in the city, but if you get well instead you can earn money to pay for a much nicer trip that will be more fun.
From what you say it sounds like you are still hopeful of joining the trial. Do not let that uncertain prospect divert you from seeking health -- the Lord's most glorious gift to humankind.
As your unwelcoming experience at the hands of NIH to date testifies, Dr. Nath is not conducting a trial of ME qua ICC. It is more a fatigue-oriented sort of thing. Are you, like Groucho Marx, determined to join only the country club that does not welcome you?
Should I have been misled, and should this be the greatest trial of Ramsay-ite ICC ME since whatever, don't worry about having taken treatments. This trial and others in the field will all be run by big boys and big girls who are more than capable of making statistical adjustments in the event that 1. it seems propitious to place you in a trial, and 2. you shock everyone by returning to health.

 

[RYO]

@deboruth @sarr88
While I agree with most of your points, let me offer a few other thoughts. NIH and Dr. Nath are planning additional studies once the intramural study is complete in Sept of 2020. I share the sentiment as with many others that this process is painfully slow. Dr Nath stated during a Solve ME/CFS webinar that they will likely embark in a treatment trial hopefully targeting a disease process that is elucidated during deep phenotyping trial. Participating in the first NIH trial will likely increase your chances of being chosen for the treatment trial.

But again, the NIH's timeline is painfully slow. I would consider exploring other ME/CFS trials such as those offered at Bateman Horne Center in Salt Lake City or seeking out Dr. David Systrom at Brigham in Boston. In general, we are all waiting for the tide of research to rise. Currently we are all stuck in a quagmire of an orphaned disease. My viewpoint is that any quality research whether it be slow is better than no research at all.

 

[*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.

Can you just tell what the stipend is? Is it dependent upon something or is it the same for everyone?

GG

 

[*GG*]

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?!

GG

Thought someone mentioned taking the verbiage and putting it in a Word doc or the like. I tried, not sure if it is my computer, or the website doesn't let you copy and past?

I have sent an email along to angelique.gavin@nih.gov asking for a write up and more info.

GG

 

[JaimeS]

I hope to have an article on this sometime soon. If/when, I'll post a link here.

 

[RYO]

Can you just tell what the stipend is? Is it dependent upon something or is it the same for everyone?

GG

Stipend is $600 for part 1 and $1000 for part 2 (extra $200 if you agree to muscle biopsy as part of part 2).

 

[*GG*]

Thought someone mentioned taking the verbiage and putting it in a Word doc or the like. I tried, not sure if it is my computer, or the website doesn't let you copy and past?

I have sent an email along to angelique.gavin@nih.gov asking for a write up and more info.

GG

I got a response, been ill 15 years here, so I do Not fit the criteria.

"We are recruiting patients who are within 5 years of symptom onset, with symptoms which began from an infection."

GG

 

[sar88]

@deboruth @sarr88
While I agree with most of your points, let me offer a few other thoughts. NIH and Dr. Nath are planning additional studies once the intramural study is complete in Sept of 2020. I share the sentiment as with many others that this process is painfully slow. Dr Nath stated during a Solve ME/CFS webinar that they will likely embark in a treatment trial hopefully targeting a disease process that is elucidated during deep phenotyping trial. Participating in the first NIH trial will likely increase your chances of being chosen for the treatment trial.

But again, the NIH's timeline is painfully slow. I would consider exploring other ME/CFS trials such as those offered at Bateman Horne Center in Salt Lake City or seeking out Dr. David Systrom at Brigham in Boston. In general, we are all waiting for the tide of research to rise. Currently we are all stuck in a quagmire of an orphaned disease. My viewpoint is that any quality research whether it be slow is better than no research at all.

HI I am not sure why that response I wrote months ago was just put on this thread and I am confused haha. I am not going to do treatment as anything I do to help AE makes ME worse visa versa. I am pretty much 99.9% positive of my journey to ME and how to correct it at this point If I just had access to the testing I need to confirm. I started with NIH because they do all the testing I just described from genome to autoantibodies in CSF. I have been trying to get into the NIH research study for the last 3 months. I have given them well more than enough to fulfill all their criteria, Yet Brian called me once again to tell me “ umm I got records from when you got it in September 2014 then nothing after that until March 2015. Umm that will not be enough documentation for our purposes unfortunately.”

There is only a lapse in documentation of 6 months when I relied on my professors who are licensed clinicians to help me as I was trying to finish school! I could not even get into a primary care within that amount of time in Boston. I fit all criteria perfectly so this makes me think they are trying to find some reason to exclude me. It honestly seems like they have outcomes in mind and they are trying to find ppl that will produce those outcomes. I am sitting here wanting and willing to suffer through all the test and could do so because of where I am on the spectrum physically. I just think we need to look into NIH and their selection process. It does not seem ethical nor correct for the ME community. I think it is extremely important to address and follow up with NIH because they are the ones who have the power (money) to give.

 

[Zenzan222]

@RYO @viggster I just got accepted into the NIH intramural study, and I’m heading to Bethesda next month for phase one.

I’m definitely concerned about the PEM consequences of participating, and just how hellish I might feel when I’m out there (especially in the metabolic chamber) but I’m also laughing inside at how excited I am to be part of such an interesting research project. My inner scientist is geeking out a bit.

It also makes my own disease a bit more real for me, strangely enough. Even though I got diagnosed at Mayo in Rochester, which is a very credible place to be diagnosed, I still find myself wondering if this is all real. It’s just such a weird disease, and it’s so ignored and downplayed by doctors and the general public, it messes with my mind. If I made it into this study, though, that’s one more reason to stop questioning myself. Hopefully phase 1 will be informative for me as well as them.

I’m happy to answer any questions others may have, and I love to talk to anyone else who’s participated. I’ll keep y’all updated on the process if you’re interested. Here goes nothin’, I guess!