Open Protocol: Multimodal MRI of myalgic encephalomyelitis/chronic fatigue syndrome: A cross-sectional neuroimaging study 2022 Shan et al

Mij · Mar 2, 2023

Upright and lying down interviews between pts would be interesting.

hibiscuswahine · Mar 3, 2023

Mij said: ↑

Is this done to induce PEM before imaging?
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No, not physical PEM, could be cognitive PEM, not sure

Oops...just checking through trials open and was posted in Oct 2022 on here, clearly they do not have enough study participant yet
https://www.s4me.info/threads/proto...ging-study-2022-shan-et-al.29784/#post-446180
(Threads since merged)

The explanatory model of the research and protocol is in this scientific paper in Frontiers of Neurology.
https://pubmed.ncbi.nlm.nih.gov/36188362/

Useful bits for other questions:

This study investigates NVC using multimodal MRIs:

(1) hemodynamic response function (HRF) that represents regional brain blood flow changes in response to neural activities and will be modeled from a cognitive task fMRI;
(2) respiration response function (RRF) represents autoregulation of regional blood flow due to carbon dioxide and will be modeled from breath-holding fMRI;
(3) neural activity associated glutamate changes will be modeled from a cognitive task functional magnetic resonance spectroscopy. We also aim to develop a neuromarker for ME/CFS diagnosis by integrating the multimodal MRIs with a deep machine learning framework.

Methods and analysis: This cross-sectional study will recruit 288 participants (91 ME/CFS, 61 individuals with chronic fatigue, 91 healthy controls with sedentary lifestyles, 45 fibromyalgia). The ME/CFS will be diagnosed by consensus diagnosis made by two clinicians using the Canadian Consensus Criteria 2003. Symptoms, vital signs, and activity measures will be collected alongside multimodal MRI.The HRF, RRF, and glutamate changes will be compared among four groups using one-way analysis of covariance (ANCOVA). Equivalent non-parametric methods will be used for measures that do not exhibit a normal distribution. The activity measure, body mass index, sex, age, depression, and anxiety will be included as covariates for all statistical analyses with the false discovery rate used to correct for multiple comparisons.The data will be randomly divided into a training (N = 188) and a validation (N = 100) group. Each MRI measure will be entered as input for a least absolute shrinkage and selection operator-regularized principal components regression to generate a brain pattern of distributed clusters that predict disease severity. The identified brain pattern will be integrated using multimodal deep Boltzmann machines as a neuromarker for predicting ME/CFS fatigue conditions. The receiver operating characteristic curve of the identified neuromarker will be determined using data from the validation group.
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Canadian Consensus - not ideal but not sure that will be too problematic, (many of the ME patients might be recruited from the YOU + ME patient registry - they have to do multiple surveys to be accepted into research)

It is not orthostatic stress i.e. comparing sitting to standing. The fMRI machine will most likely have a horizontal trolley into the MRI machine

It is important to assess anxiety and depression as this may alter performance on cognitive tasks

Looks like they are looking at the autonomic nervous system, hypocapnia levels with CPET's etc due to ME's unusual responses (respiratory alkalosis), mismatches in the inspiratory and expiratory phases of respiration

Breath holding data I think is around this. (A radiologist would know more about the technical aspects of fMRI and validity to test system in this way @SNT Gatchaman)

The training group with the cognitive task is the "active group"
The validation group are the comparison group i.e. the "controls"

They will want people with fibromyalgia (so do not have ME).

It is a big radiographic study and they are going to look for severity in the data, as mentioned, by analysing the brain mapping of the glutamate and blood flow.

DokaGirl · Mar 3, 2023

@Hutan

I guess if Dr. Shan's work is pretty good, does he use the CCC or ME-ICC?

Should be interesting. We need more ME brain studies.

hibiscuswahine · Mar 3, 2023

DokaGirl said: ↑

@Hutan

I guess if Dr. Shan's work is pretty good, does he use the CCC or ME-ICC?

Should be interesting. We need more ME brain studies.
Click to expand...

It is CCC. just did a reply on it.

Hutan · Mar 3, 2023

The risk of an ill-defined ME/CFS patient cohort will be mitigated by employing a consensus diagnosis of ME/CFS from two clinicians (R.A.K and P.D., both have over 10 years of experience in ME/CFS) and using the Canadian Consensus Criteria (CCC) 2003
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Re diagnosis, they also have two clinicians both confirming the diagnosis. They are choosing controls with a sedentary lifestyle.

This project started when the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred before the long Covid (post-acute sequelae of SARS-CoV-2 infection) was recognized. We decided to keep the study protocol and follow the CCC ME/CFS criteria while considering SAR-CoV-2 as an infection similar to other infections that occurred before the manifestation of ME/CFS.
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A nice way of dealing with new cases of ME/CFS, some of which will be after Covid-19, I think.

hibiscuswahine said: ↑

The training group with the cognitive task is the "active group"
The validation group are the comparison group i.e. the "controls"
Click to expand...

I think the training and validation is for the data. So, all the participants do the same thing. Then, the researchers analyse half of the data and see what they conclude. And then analyse the second half of the data, and see if the findings are the same. Sort of a study and a replication of it in one study.

hibiscuswahine · Mar 3, 2023

Hutan said: ↑

I think the training and validation is for the data. So, all the participants do the same thing. Then, the researchers analyse half of the data and see what then conclude. And then analyse the second half of the data, and see if the findings are the same. Sort of a study and a replication of it in one study.
Click to expand...

Yes, not absolutely sure, may have read it wrong, validation does mean checking the results were right I think, maybe repeating it of getting an independent person to look at them....

Research methods pretty hazy from first being educated in them, but come out if prompted but memory and cognitive function do fail me often.

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