USA: National Institutes of Health (NIH) intramural ME/CFS study

The 50 "controls" are patients who had COVID and got better, so they're trying to figure out why some people recover and others don't. This might be a faster, more productive study than one done on ME/CFS patients because, in long covid, there's presumably only a single pathogen involved, as opposed to the multiple triggers that there seem to be in ME/CFS. That might make the mechanism behind the chronic cases easier to discover and that could benefit people with ME/CFS as well as long covid.

On the same call, Nath talks about making public the data that they already have:

 

Thanks @Forbin for helping to clarify.

Maybe they'll have an easier time recruiting long COVID patients.

I hope they will make good on Nath's quote to "publish whatever we have right now". At the very least it would help to build / sustain trust between NIH and patient groups, even if the research findings are incomplete.

 

I just read the transcript from the March 30th call. I have to say I'm disappointed even by me/cfs standards.

How can you have a mandate to complete an intramural study for a underfunded, underserved condition and just drop it with ambiguous (read none) plans to return? Don't get me wrong, I'm glad staff will take time to look at the data more carefully, but have they not have a year to do that if it "ground to a halt" when the pandemic started? But I am worried that they are abandonig a project half completed with low patient number powered research, since the whole idea was this would give us some more definitive answers.

If this study was Collins attempt to mend broken promises and rebuild trust, I have to say it is a collosal failure to date. From the obsession with a 3-year recruitment cut-off or Shorter coming to speak at the NIH to disappearing with a wimper.

I mean, it's good that they are looking at long-haul covid, but I'm not filled hope. I also have no idea what to make of those brain comments from Nath, or it's relation to me/cfs (or long-haul based on the circumstances).

 

2 Studies on post-covid by Avi Nath. Both started before the end of last year and are not me/cfs specific.

https://clinicalstudies.info.nih.go...ry=Observational Neurologic COVID-19#contacts

Neurologic symptoms.

https://clinicaltrials.gov/ct2/show/NCT04573062#contacts

Natural History.

Cort Johnson has a write up, here, from a patient that participated in the neurologic symptoms study. Despite that patient describing me/cfs symptoms, the criteria don't seem to be me/cfs specific at all, and obviously the timeframe for the illness is almost always less than a year.

 

Anyone know if there are any updates from this study?

 

Last update it was stopped, about a year ago. Haven't heard anything since so fair chance they just took advantage of the pandemic to quietly end it. It seems to have switched to long haulers, which is kind of the same but no word and anyway they've only published one small paper of no consequence in, what, 4 years, so at this point I expect nothing will come out of this, there is just no interest there. Given the allocated fund, I doubt this program even runs anymore for LC, what would even be the point? They have no one full time and no institutional resources or support. It's Potemkin stuff, all façade.

Everything depends on the $1.15B fund. Long Covid has made it clear that nothing was going to move at all for us and this fund is probably the only real chance we will ever have, either that or chance and technological progress solve it anyway. Or maybe another pandemic happens and does it all over again. Or the next. Or the one after.

 

This is entirely anecdotal, but I had an appointment with my ME/CFS doctor last week and he had spoken with Dr Nath. Dr Nath said that after the papers are written up and submitted for the research done so far, the plan is to reopen the study with an emphasis on treatment. My doctor was calling with respect to a particular patient and Dr Nath was very encouraging about the patient coming to NIH when that phase of the study starts.

 

I wonder if anything from this study will ever see the light of day.

Interestingly, it is now showing as "recruiting" once again: https://clinicaltrials.gov/ct2/show/NCT02669212

 

Dr. Nath may have good information on the 23rd.

 

Sorry! I should have included the link, in case anyone wants to attend.

https://sites.google.com/massmecfs.org/2021annualmeeting

 

Greetings Fellow ME Crusaders - This is my maiden voyage in the forum, so hopefully this inaugural post proves informative.

As the NIH website indicates that the intramural study is again actively recruiting, I contacted the patient coordinator for clarification. She informed me that the study is indeed suspended and that conversations regarding its continuation are ongoing. However, she unequivocally asserted that if a resumption of study activities were to occur, it would not transpire until 2022 at the earliest.

I pressed her for some actionable intelligence regarding preliminary findings, and while she could not disclose specifics, she seemed bullish about certain anomalies providing fertile ground for continued exploration.

P.S. Professor Mike Sharpe unceremonious blocked me on Twitter. I felt this fact might enhance my forum cachet lol!

 

Thanks for doing that, it's important to keep track of that study. It would be a shame if they just dissolved it without much fanfare or, more importantly, without replacing it.

 

My dream outcome for the intramural study is actually not that they restart it, but that something so intriguing comes out of the preliminary results that they promptly fund an RFA - set-aside funding - so that extramural researchers can follow up on it. Might as well dream big!

 

Merged thread

===
Source: Clinical Trials
U.S. National Library of Medicine
Date: December 7, 2021
URL: https://clinicaltrials.gov/ct2/show/NCT02669212


Myalgic Encephalomyelitis Chronic Fatigue at the National
Institutes of Health
---------------------------------------------------------

Brief Summary

Background
Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.

Objective
To learn more about PI-ME/CFS.

Eligibility
Adults ages 18-60 years who have finished at least 7th grade education and either:
* have ME/CFS that started after an infection
* OR had Lyme disease, were treated, and returned to normal health
* OR are healthy volunteers

Design:
Participants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:

Medical history
* Physical exam
* Intravenous (IV) line. A thin plastic tube is inserted into a vein.
* Blood and urine collected
* Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.
* Grip strength tested
* Saliva, cheek swab, and stool collected
* Tilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection
* Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.
* Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
* Heart monitoring
*Sleep study for participants with PI ME/CFS
* Questions about the participant s life and how they are feeling
* Questions from a neuropsychologist
* Questions from an occupational therapist for participants with PI ME/CFS
* Questinos from a nutritionist

After the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.

Eligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.

Participants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:
* Sleeping in a room that measures how the body uses energy with EEG monitoring
* Eating a controlled diet
* Performing vigorous exercise for 10-15 minutes
* Questions about how participants are feeling
* Questions about what participants usually eat
* Samples of saliva, blood, urine and stool
* Wearing an activity monitor
* Having an Xray that measures body composition
* Thinking and memory tests
* Heart monitoring
* Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.
* Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.
* Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.


Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 345 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Actual Study Start Date: October 10, 2016
Estimated Primary Completion Dateecember 30, 2024
Estimated Study Completion Date: June 30, 2025

(...)


Contacts and Locations

Contacts
P.I.: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Locations
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States, 20892

--------
(c) 2021 U.S. National Library of Medicine
===

from m-a fluks.

===

i think we really need pwme scientific observers / collaborators integrated into their study design etc. [edit: i previously said participants, which was ambiguous.]

 

I think we need less people making up new names every month.

 

Is the only way forward to intentionally harm patients to see how badly they are affected?
Physical exertion (travel to NIH) + metal exertion + physical exertion + metal exertion + travel back home = PEM catastrophe

 

The study remains indefinitely suspended. So I have little to no idea why they’re updating the clinical trials database? Also, apparently a compendious waiting list exists despite the undertaking only attracting a smattering of participants over the last five years.

It all makes perfect sense if you don’t think about it!

 

The only "emotional discomfort" I've experienced since being infected is primarily due to the gaslighting, neglect and downright hostility I've experienced at the hands of the medical establishment.

 

I guess I would wonder "how long after an infection?"... like within a week? A month? I think some long covid cases have developed even later than that.

Also, "after an infection" could mean mean "after the initiation of an infection" or "after an infection has resolved."

Not trying to be picky. I think the infection requirement is probably a sensible way of trying narrow things down. Mixing infectious onset with, say, chemical exposure onset might confound things when so little is known about the mechanism of either.