2024: USA NIH NINDS ME/CFS Research Roadmap - input on research priorities sought by 11 March 2024

OK, I managed to hold it together long enough to log in and make a suggestion. Not a good day for me to be honest. Hope it is helpful.


https://ninds.ideascalegov.com/c/idea/32743

 

Deadline extended to March 11: NINDS is seeking feedback on ME/CFS Research Roadmap priorities !!!!

 

Deadline extended to March 11: NINDS is seeking feedback on ME/CFS Research Roadmap priorities



NIH MECFS Information List <NIHMECFSInformationList@mail.nih.gov>
(12 minutes ago)



to NIH-MECFS_INFORMATION



The deadline for providing input and feedback on the ME/CFS Research Roadmap research priorities has been extended to Monday, March 11 at 5pm ET. Learn about the draft research priorities by visiting IdeaScale. Comments may include input on how the draft research priorities could be enhanced, new research questions that could be included, or challenges that the current research priorities may face. Comments will be public so please do not include any personal and/or medical information.


There are two ways to share your feedback:


Option 1: IdeaScale

To submit feedback, visit the IdeaScale website

To learn how to use the IdeaScale website, watch this instructional video


Option 2: Email

We recognize that IdeaScale can be challenging to navigate, so you can also provide feedback on any of the research priorities to: mecfsresearchroadmap@ninds.nih.gov


When you submit your feedback via email, please also include the following:

1. Would like us to post your feedback/comments on IdeaScale for you? Answer: Yes/No
2. Would like us to post your feedback/comments anonymously or with your name? Answer: Anonymously/With my name: please provide your full name

Please send any questions about this process to: mecfsresearchroadmap@ninds.nih.gov


To learn more about the ME/CFS Research Roadmap and to view the webinars, visit the ME/CFS Research Roadmap Working Group website.

 

So that's 10pm GMT?

 

yes
https://www.timeanddate.com/worldclock/

 

Has anyone asked them to do a similar study as this one, but on/with people with ME?

https://www.tcd.ie/news_events/articles/2024/trinity-team-discovers-underlying-cause-of-brain-fog-linked-with-long-covid/

 

Update from NIH - Deadline for feedback extended until Monday, March 11 at 5 PM Eastern Time

EDIT: Posted this in a hurry this morning, without checking the thread, so I didn't see that it was a duplicate!

 

I uploaded my idea as a submission but it remains pending approval more than 24 hours later. Lots of other ideas were approved in the interim, so I'm being censored. I suspect this is because of my paragraph naming Wallit. Disgusting that they won't publish sensibly worded criticism of them.

I have resubmitted each paragraph of my submission as a separate idea. We'll see if we can get past the censors.

Thanks, I intended to incorporate your comment but had a crash so didn't have the ability to add a sentence to this effect when I uploaded it.

 

I submitted this comment:

Funding for Researchers working on the Biological Basis of ME/CFS
The NIH needs to make it clear, that only researchers working under the assumption that ME/CFS is a biological disease will be funded or supported. We should not tolerate those individuals who wish to psychologize the disease or introduce terms like "effort preference" which contain a psychological connotation. The evidence is so overwhelming that ME/CFS is a biological condition that those who do not support this need to be excluded from the field. There are so many good researchers out there who have such limited funding that even entertaining those who have a psychological inclination should not be permitted.

It took them about a week to approve it unlike the other comments I made. Perhaps Vicky needed to discuss which comments are appropriate with other members of the NIH.

So annoying that you can't edit the comments once submitted. That misplaced comma is really annoying me.

 

Well that basically confirms they are delaying publishing any mention of effort preference.

 

Update from Colleen Steckel on what she has submitted. It's possible to clap to support them but she has also commented about claps.


Image from IdeaScale limiting claps each day.
“Claps” are limited
In using the IdeaScale to give comments as well as respond to other comments, I discovered an issue with the platform.

For each comment they offer the option to “clap” (like) a comment. Unfortunately, the system severely limits how many comments a person can clap on each day. Once the limit is reached a pop-up states:

“You don’t have any claps left to give today. Come back tomorrow!”

As I was attempting to go through the comments near the deadline, there weren’t enough days left to “come back tomorrow”. Having to come back another day ignores the limitations imposed by myalgic encephalomyelitis!

To get around this problem, I emailed a list of the titles of the comments that I wanted to support to mecfsresearchroadmap@ninds.nih.gov.

I received a response from Vicky (last name not given) indicating she didn’t know there was a limit to the number of claps possible. The following was my response:

I am surprised you weren't aware of this limitation, but now that you know please realize that the number of claps is zero indication of the level of support for any one comment. I suspect most would not (could not) do what I did to let you know what other items they support. So if you are considering utilizing the claps in your assessment, maybe allow another month for just claps?

She followed up to say she is checking into this and would get back to me. I haven’t heard back but I see the deadline was extended for a few more days.

As of this writing, the limited clap issue was not resolved because I am again locked out from clapping.

An alternative is to offer a supportive comment under each item. This presents a large hurdle which severely limits stakeholder input.

Because of this limitation they should NOT put any weight on the comments based on the claps it receives.

Supporting my comments
Should anyone want to “clap” on my comments, it seems the only way to reliably give support is to send an email to mecfsresearchroadmap@ninds.nih.gov and tell them which comments you support..

Below are the posts or comments that I made on the IdeaScale platform.

I hope they are listening!

Colleen

Comments I submitted:
Post-exertional neuroimmune exhaustion
Post-exertional neuroimmune exhaustion is clearly described in the International Consensus Criteria (ICC) and the International Consensus Primer for ME.

Post-exertional malaise is a much more vague symptom description that is being used in other patient populations (like MS).

We need research to clarify the experience of post-exertional neuroimmune exhaustion as compared to those who have other conditions with PEM. Are we talking about the same experience with different labels? Or are these two different energy production issues?

This knowledge of whether these are two different energy production issues will have a profound effect on all future research.

Stratify Patients
One of the biggest variables in ME research has been patient selection. Patients have been used in “ME” research who were selected based on a vague description of fatigue but not screened for ME.

Researchers need to understand that doctors diagnose using broad clinical criteria, but this is insufficient for research purposes.

The International Consensus Criteria (ICC) is both a clinical and research criteria. We need doctors to screen all who have been given the clinical diagnosis of ME/CFS to follow up and screen using the ICC. As we saw in the recent NIH intramural study, too many patients in research are not getting thoroughly screened.

We need the researchers to utilize research criteria and stop using clinical criteria for patient selection. The NIH must help promote education of doctors to learn how to screen using the ICC. Doctors knowing how to diagnose ME is needed so researchers have best patient selection in their studies.

Stratify patients beyond just criteria

The following are some stratification categories that have shown to be important in previous research:

• Severity (mild, moderate, severe, very severe)
  
  
• Gender
  
  
• Onset type (gradual/sudden)
  
  
• Pre/post menopause
  
  
• Age
  
  
• Length of time ill
  
  
• Suspected pathogen at onset.
  
  
• Note: As ME causes immune dysfunction, it is important to take into account that the suspected pathogen at onset may have been a reactivation of an earlier pathogen.
  

As the IC Primer states on page iv

“Research on ME: The logical way to advance science is to select a relatively homogeneous patient set that can be studied to identify biopathological mechanisms, biomarkers and disease process specific to that patient set, as well as comparing it to other patient sets. It is counterproductive to use inconsistent and overly inclusive criteria to glean insight into the pathophysiology of ME if up to 90% of the research patient sets may not meet its criteria (Jason 2009). Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.

Research confirmation: When research is applied to patients satisfying the ICC, previous findings based on broader criteria will be confirmed or refuted. Validation of ME being a differential diagnosis, as is multiple sclerosis (MS), or a subgroup of chronic fatigue syndrome, will then be verified.”

We now have several research papers that show the importance of stratifying patients.

The importance of stratification applies to ALL the research. In order to know if a finding applies to the ME patient group, we need research done using ME patients as defined by the ICC.

TRPM channelopathy research
The June 2023 paper, Altered TRPM7-Dependent Calcium Influx in Natural Killer Cells of ME/CFS Patients, by Du Preez, Eaton-Fitch, Smith & Marshall-Gradisnik brought to light the importance of transient receptor potential melastatin research.

This is an important area of research that may lead to curative treatments. We need to bring more TRPM researchers into the field of studying ME. We need to make sure that all TRPM research utilizes stratification by strictest criteria (ICC), gender, type of onset, pre/post menopause, severity of illness, etc.

qEEG study to investigate the anatomy underlying the reduction in brain electrical activities (theta waves) - my comment under that post.
A follow-up of the research, Quantitative Electroencephalographic Assessment of Myalgic Encephalomyelitis / Chronic, by Andrew E. Pellegrini is another approach to qEEG to consider.

Key to any research is stratification of patients utilizing best research criteria (ICC) and other factors such as gender, age, type of onset, severity of illness, etc.

https://drive.google.com/file/d/1u9KO3N0QuoWB9fLS3roHX9E-JVsLiEpx/view

ME/CFS Diagnostic biomarkers need to be our focus - my comment under that post.
I agree that focusing on a biomarker is important. I also agree that patients need to be stratified by strict criteria. As the ICC is an update of the CCC and the CCC was not designed to be a research criteria, I would like to see researchers focus on the ICC for research. If CCC (or other) criteria are used we need to know which results in a study applied to which patient group.

There are a number of studies that could lead to biomarkers that need to be followed up such as:

Using EEG as done in this study, EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients-A case control study, from 2011.

Consequences of sarcolemma fatigue on maximal muscle strength production in patients with ME/CFS from 03 August 2023

Altered TRPM7-Dependent Calcium Influx in Natural Killer Cells of ME/CFS Patients from 26 June 2023

Increased gut permeability and bacterial translocation are associated with fibromyalgia and ME/CFS: implications for disease-related biomarker discovery from September 2023

Skewing of the B cell receptor repertoire in ME/CFS from 27 March 2021

Diffusion Tensor Imaging Reveals Neuronal Microstructural Changes in ME/CFS from 06 August 2021. This study showed the importance of separating Fukuda group from ICC group. "The group analysis using a voxel-based method detected differences in diffusion metrics in ascending and descending tracts in the medulla, pons and midbrain of the brainstem in ME/CFS patients, but only for those meeting ICC criteria."

Association of circulating biomarkers with illness severity measures differentiates myalgic encephalomyelitis/chronic fatigue syndrome and post-COVID-19 condition: a prospective cohort study from 16 December 2023

Biomarkers for ME/CFS: a systematic review by Maksoud, Magawa, Eaton-Fitch, Thapaliya & Marshall-Gradisnik from 24 May 2023 offers a number of possible avenues.

See links to many of these studies & more here: https://drive.google.com/file/d/1YxFB3LBb3FODLYmjtFQqW0WCzHKFP7GE/view

See more possible biomarkers here: https://drive.google.com/file/d/1PnP_wInEKvd7MZfEtavhzi-w0aCG1tn1/view

 

It's unfortunate that this came out around the time of the NIH study. Both take energy ( I prefer that word to effort because it is more accurate ) which is in short supply for pwme. There also seem to be a number of hurdles to jump in order to participate.

 

My comments have now been published. Looks like Vicky was working over the weekend.

 

I’m having trouble registering for the website they sent me an email link that doesn’t work….

 

If you're quick you may be able to get Vicky to post on your behalf. I emailed her and she did for me

mecfsresearchroadmap@ninds.nih.gov

 

Am struggling to get in. Heavy pem after family visit yesterday. I wanted to clap an entry ( I didn't think existing claps were visible) which had 24 claps and write a very brief comment.
Will try later if I improve but pem will worsen at this stage not improve. So frustrating.


edit : process not suited to ME

 

Submitted as an email......ran out of time (and interest) to deal with the website system.....

ETA was posted by Vicky.

 

Posted very brief comment via email.


edit: I added 5 hours to 5pm ET and it came to 11 pm so it was late. Truly bad LEM/PEM!!
edit2: Lesson learnt- if writing in pem, triple check every detail or better still don't write!

 

Emailed this at "9:58 PM" (UK time)*. My wife told me to do it earlier - why do I keep making the same mistakes (re time management)!
My keyboard doesn't have "M" & "n" - some typos!
Forgot to indicate whether I wished to have my name published (or indeed include my address etc.) - kind of hoping they'll come back to me on that!


*"Research priorities -
1) Genetics -

• whole genome sequencing to look for rare variants. Possibly a family study i.e. families with more than 1 member affected and at least one severe;
• GWAS - depending on outcome of DecodeME. Experience from e.g. dementia indicates that large studies may be required to find target genes.

2) Immunology -
Maureen Hason's talk i.e.

• indicating the need to look at other cell types e.g. monocytes. I think Professor Joatha Edwards has said [Science 4 ME] that B-cells have been extensively studied and not much found;
• Platelets seem to be different in ME/CFS [Hason].

3) Metabolism -

• Raman spectroscopy may provide a diagnostic tool and appears to be a useful research tool e.g. differentiating ME/CFS from other illnesses ad identifying compounds which contribute to those differences (amino acids);
• as highlighted by Vicky Whitteore, major gaps in metabolic coverage, run in parallel with Raman spectroscopy these see to be routes to potentially identify abnormalities which could be used for diagnosis and providing insight into disease mechanism.
• As highlighted by the speaker from Jackson - need to use currently available immunological techniques and combine these with metabolics - that may yield insight into areas to focus research.