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

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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
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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 Date:December 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

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(c) 2021 U.S. National Library of Medicine
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from m-a fluks.

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

* have ME/CFS that started after an infection
Click to expand...

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.
 
Forbin said:
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.
Click to expand...
Good point. In my case, I had EBV early November 13 years ago. confirmed by lab. I felt horrible, unable to work, but mainly exhausted with liver pain. In 5 months I managed to fail 2 return to work attempts, was found to have a large ovarian cyst and got a necrotic gallbladder. It was a month later that i experienced my first orthostatic intolerance symptoms along with depth perception problems, heat light and sound sensitivity.

You have to give someone a chance to recover from their initial infection before you can diagnose them with ME or even long-COVID, whatever that means to them (and i’d wager even doctors do not know what the long covid case definition is) ; chances are, they will.
 
Merged thread

#MEAction: Research Update: The NIH Intramural ME/CFS Study, May 2022

https://www.meaction.net/2022/05/04/nih-research-update/

Some quotes:

Nath said the study has identified consistent biological problems in ME/CFS patients, who spent up to four weeks as NIH inpatients over two visits. “It was important to convince ourselves that there really are biological problems that are reproducible and consistent, and to develop expertise to study ME/CFS, because we hadn’t looked at it before. Then we will move on to treatment studies. We have a number of different candidates [drugs] we would like to try.
...
With patient investigations ended at the start of the pandemic, Nath assembled five working groups to analyze the ME/CFS study’s huge data sets. “We had an immunology group, a physiology group, and so on,” he said. “The analyses are very cumbersome and take a long time. It’s all slower than anyone wants, including myself.”
...
Last fall, Nath and the study’s lead clinical investigator, Brian Walitt, began meeting every weekend to synthesize the findings and to write up the results. Nath, who has an extensive track record of publishing research in top journals, and whose research is cited more than 45,000 times in the medical literature, said, “I’ve never written a paper of this huge magnitude in my life. I feel badly that it’s taken so long. But we have so much to synthesize, Brian and I. Today we were working on the discussion section,” which usually appears at the end of a research report and tries to put the results in a larger context.
...
_________________
More at the link

Nath says he will not publish a preprint or release results in advance of publication, so I'm guessing it could be a year or more before we see a published paper.
 
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Moved from the News from NIH thread

Trish said:
Update on the NIH intramural ME/CFS study posted on this thread:
#MEAction: Research Update: The NIH Intramural ME/CFS Study, May 2022
Click to expand...
Research Update (NIH Intramural ME/CFS Study) said:
Nath said the study has identified consistent biological problems in ME/CFS patients, who spent up to four weeks as NIH inpatients over two visits. “It was important to convince ourselves that there really are biological problems that are reproducible and consistent, and to develop expertise to study ME/CFS, because we hadn’t looked at it before. Then we will move on to treatment studies. We have a number of different candidates [drugs] we would like to try.”
Click to expand...
(my bolding)

That sentence that I marked in bold immediately stood out.

But then I thought, maybe it could be interpreted in multiple ways?

The more generous interpretation is that researchers did believe that ME/CFS patients had biological problems. They just didn't know what those problems were, or how to measure them in a way that would be reproducible.

However, I confess that the sentence sure feels like NIH researchers saying they weren't sure at first whether there "really are biological problems" in ME/CFS patients.

Thoughts?
 
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I think they are saying that they needed to suspend judgment until they could see real results that were robust ie consistent and reproducible. I read it as suggesting that they were making no claims until the science backed it up.
 
Maybe he could ask someone else to help then, instead of only Wallitt? Personally, I highly doubt that anything analysed or written by someone with such strong prejudices (as the ones Wallitt has expressed) would be reliable in this context. :grumpy:
 
Avi Nath said:
It was important to convince ourselves that there really are biological problems that are reproducible and consistent, and to develop expertise to study ME/CFS, because we hadn’t looked at it before
Click to expand...
As much as this is... interesting to hear, it's admission of having failed to do their job properly for decades. Which we know, even said so. But that something this massive can be said as an afterthought, with zero expectation that it has any importance, says everything about why everything failed. There is simply no accountability, no expectation of delivering anything. People are simply there, along for the ride, have no agency when they fail, even though it's through their agency that they chose to fail. He probably means convincing others, I think that Nath is one of the few who get it, but this is a major disaster requiring accountability relative to the harm done.

If this were a criminal investigation, with prosecutors admitting that they literally did not bother looking at exonerating evidence, and now that they did, well looky here... innocent. Oops. There could be consequences, not necessarily would. It would all depend on who did what, who was hurt, who is responsible for the failed decision-making, who is in charge right now and how embarrassed they would be for the failure of like-minded peers when they made the same decisions themselves.

Chronic illness has been de-medicalized. Now it needs to be de-politicized, right along with literally all healthcare. In almost any other job people would get fired, entire departments would be reformed. Millions of lives were ruined, and... nothing. No one cares, it's business as usual.
 
rvallee said:
As much as this is... interesting to hear, it's admission of having failed to do their job properly for decades.
Click to expand...

That failure compounding into the Long COVID disaster that adds to the ME/CFS burden: both in patient numbers and continued lack of diagnostics/therapies.

Nath admitted that it has taken him too long to complete and write up the research. “COVID has pretty much taken over my life,” he said. In March 2020, the Clinical Center closed to most patients, ending enrollment a few patients short of the initial goal. Nath then began autopsy studies of people who died of COVID-19 and eventually began studying people with Long COVID, or as the NIH terms it, post-acute sequelae of COVID. Nath has said that many cases of Long COVID strongly resemble ME/CFS.
Click to expand...
 
> Nath says he will not publish a preprint or release results in advance of publication

i wonder why we can't get a small formal self-contained report that not impede the big paper. even a well-annotated subject flow diagram. least publishable unit is sardonic but perhaps it could be useful. from my uninformed perspective.

i don't want results to peter out or get cancelled or be put on hold or any number of bureaucratic tricks. or be corrupted / elided, spin control, or approval by koroshetz or whoever to be the focus of the paper. etc.

and why not have some truth-oriented young scientists without ontology-challenged brains assist.
 
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It will get significantly more attention from scientific community if published in a good journal. I’d rather he follows the peer review publishing steps to do this properly even if slower. Scientists are as skeptical as we all are about badly done or hyped studies in crappy journals. I hope this is a game changer for us, and headline news on Science or Nature mags.
 
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