disqualified to participate in CFS study at Stanford due to RLS!

[hmnr asg]

hi everyone,
As a new patient of the lab where Dr Montoya works in the Stanford infectious disease clinic, i was asked to consider participating in two research studies.
I filled out the required online forms and I was very eagerly waiting for their response.
Yesterday I received this email:

Subject: Stanford ME/CFS MRI Study
Email: Thank you so much for your interest in our ME/CFS MRI Study! Unfortunately, restless leg syndrome does make you ineligible for our study.

I am a bit baffled by this. I understand many things would disqualify a person from participating. But RLS? I think many of us have RLS (just guesstimating here I would say around 1/3?). If anything I think RLS is very strongly correlated with CFS and so precluding such patients from participation would surely skew the results away from the mean.
Am i wrong here? what do you guys think?

Thanks

H

 

[alex3619]

Studies have very strict exclusion criteria in order to create as homogeneous a cohort as possible. I was rejected from a study some years back, though in my case there were probably stronger grounds. I don't think its unusual, but its definitely disappointing. There is probably a specific reason for rejecting someone with RLS, but if its not made public we are only guessing.

 

[hmnr asg]

hi Alex,
Thank you for your response. Of course i understand the importance of having a carefully controlled inclusion criteria. I have participated in clinical trials before and I understand the need for excluding co-morbid issues. It's good to have a homogeneous sample but if its too homogeneous we might end up not getting a full picture.
Also i am not in any way disappointed on a personal level. I want proper clinical trials to be conducted so that one day we can have some hope of a treatment. I honestly wanted to participate for the good of the research in CFS. I have enough PEM that driving to Stanford is likely to have caused serious issues for me (I live an hour away).
What im curious about is the logic behind excluding one of the most frequent co-occurring diseases with CFS. And i am sure they have good reasons for it, but i wonder what that could be? It is a curious matter and I just wanted to get some discussion going. I was in no way saying they are wrong or that i know better (I guess my post came across that way :thumbdown.


H

 

[wigglethemouse]

I honestly wanted to participate for the good of the research in CFS.

@hmnr asg Have you tried Ron Davis's team at the Stanford Genome Technology Center (funded by OMF).
The patient coordinator is Anna Okumu [ aokumu at stanford.edu ] and she can give you more details. They are also looking for healthy controls - maybe a healthy could drive you and participate too? You have to be local to participate.

Here is a list of active projects the Stanford team is working on.
https://www.omf.ngo/2018/06/04/omf-funded-research-2018/

 

[Shoshana]

I too, am extremely surprised and perplexed, as to why RLS would be a cause for not being included. !

I too fully comprehend and support, the care that must be taken in selecting people for research,

yet, it seems that if too many symptoms exclude people, then, either:
those people may be needlessly excluded for unrelated things that are very common in the general population,
OR, that many who do have a symptom related to the illness being studied, might be excluded, and information may be badly overlooked and could significantly skew results.


I guess we will try to trust that they have excellent reasons for that exclusion, though I admit, I am as baffled as the original poster, on how those could be valid.

I personally found it shocking, when I read this.
Thank you for sharing that they exclude for that.
It leads me to wondering, what that might tell me about my illness(es) then, as well as about their process.

SO, it means that I too would be excluded, if I had been able to go there.
I wonder what else they think is perhaps my underlying reason for the RLS, if not related to my illness? ???

 

[wigglethemouse]

I too, am extremely surprised and perplexed, as to why RLS would be a cause for not being included. !

I'm guessing they are concerned that people with RLS may have brain abnormalities. Here is the first hit I found on Dr. Google when searching RLS and brain
https://www.sciencedaily.com/releases/2018/04/180425162023.htm

 

[maple]

My guess is they are looking for something specific ... so let’s assume they know what they are doing...

 

[hmnr asg]

@hmnr asg Have you tried Ron Davis's team at the Stanford Genome Technology Center (funded by OMF).
The patient coordinator is Anna Okumu [ aokumu at stanford.edu ] and she can give you more details. They are also looking for healthy controls - maybe a healthy could drive you and participate too? You have to be local to participate.

Here is a list of active projects the Stanford team is working on.
https://www.omf.ngo/2018/06/04/omf-funded-research-2018/

Done ! I will be going there next week. Thanks for letting me know about this.

H