Accurate and Objective Determination of ME/CFS Disease Severity with a Wearable Sensor. Palombo et al. 2020

[John Mac]

Full Title: Accurate and Objective Determination of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Disease Severity with a Wearable Sensor

Background
Approximately 2.5 million people in the U.S. suffer from myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
This disease negatively impacts patients’ ability to function, often resulting in difficulty maintaining employment, sustaining financial independence, engaging socially with others, and in particularly severe cases, consistently and adequately performing activities of daily living. The focus of this research was to develop a sensor-based method to measure upright activity defined as time with feet on the floor and referred to as UpTime, as an indicator of ME/CFS disease severity.

Methods
A commercially available inertial measurement unit (IMU), the Shimmer, was selected for this research. A Kalman filter was used to convert IMU data collected by the Shimmer to angle estimates.
Angle estimate accuracy was confirmed by comparison to a motion capture system. Leg angle estimates were then converted to personalized daily UpTime scores using a critical angle of 39º from vertical to differentiate between upright (feet on the floor) and not upright.
A six-day, case-control study with 15 subjects (five healthy controls, five moderate-level ME/CFS, and five severe-level ME/CFS) was conducted to determine the utility of UpTime for assessing disease severity.

Results
UpTime was found to be a significant measure of ME/CFS disease severity.
Severely ill ME/CFS patients spend less than 20% of each day with feet on the floor.
Moderately ill ME/CFS patients spend between 20–30% of each day with feet on the floor. Healthy controls have greater than 30% UpTime.
IMU-measured UpTime was more precise than self-reported hours of upright activity which were over-estimated by patients.

Conclusions
UpTime is an accurate and objective measure of upright activity, a measure that can be used to assess disease severity in ME/CFS patients.
Due to its ability to accurately monitor upright activity, UpTime can also be used as a reliable endpoint for evaluating ME/CFS treatment efficacy.
Future studies with larger samples and extended data collection periods are required to fully confirm the use of UpTime as a measure of disease severity in ME/CFS.
With the added perspective of large-scale studies, this sensor-based platform could provide a recovery path for individuals struggling with ME/CFS.

https://www.researchsquare.com/article/rs-48360/v1

 

[Jonathan Edwards]

This seems a simple and sensible experiment. I would like to see more complex analysis of patterns during the day but this is a start.

 

[MEMarge]

Other than the last sentence of the conclusion, which seems a bit odd, it does seem useful.

"With the added perspective of large-scale studies, this sensor-based platform could provide a recovery path for individuals struggling with ME/CFS."

I hope it means something like "this could be a useful objective measurement of physical activity, in trials of therapies for ME..."

ETcorrect: typo

 

[Trish]

That was my reaction too - what recovery path?

 

[wigglethemouse]

This is the Bateman Horne center study that Lucinda Bateman has talked about

Turner Palombo
University of Utah, Salt Lake City, UT
Andrea Campos
Bateman Horne Center, 24 S 1100 E Suite 205, Salt Lake City, UT 84102
Suzanne D. Vernon
Bateman Horne Center, 24 S 1100 E Suite 205, Salt Lake City, UT 84102
Shad Roundy
University of Utah

Corresponding Author
ORCiD: https://orcid.org/0000-0002-5256-628X

This was a Solve ME CFS Initiative Ramsay Award project

Funding
The authors gratefully acknowledge funding for this project from the Solve ME/CFS Initiative under the Ramsay Award Program. Funding was also received from the Utah NASA Space Grant Consortium.

EDIT : Here is the Solve award write-up for Shad Roundy, a 2019 awardee. Nice to see a quick turnaround from award to reporting.
https://solvecfs.org/shad-roundy/

 

[wigglethemouse]

I hope it means something like "this could be a useful objective measurement of physical activity, in trials of therapies for ME...

That was the plan. From the Solve ME/CFS application at the link above

If the proposed measure successfully detects changes in the amount of time in an upright posture, it will then be submitted to the FDA’s biomarker qualification program to qualify it for use in ME/CFS clinical trials. The existence of an FDA qualified biomarker and clinical outcome measure will be an important inducement to researchers and pharmaceutical companies to develop effective treatments.

 

[Invisible Woman]

Hmmm....it might be useful as part of a research trial to provide objective measurement.

In terms of categorizing severity - no, I don't think so. Gross oversimplification of the effects of the condition there. Especially, for those who are less troubled by POTs but might still be severe - so they might be upright longer just walk into & trip over stuff more. It also doesn't factor in the disability caused by cognitive dysfunction.

Disease severity in ME isn't terribly well defined or possibly understood. You have to factor in a lot more than how long can people remain upright.

At this point I think it can simply provide a before and after snap shot of one (of the many that need to be considered) aspect.

 

[wigglethemouse]

It's refreshing to read a paper where they discuss their failure to prove their hypothesis that the NASA 10 minute lean test would induce PEM and that that would be detectable by upright activity.

Another objective of our study was to evaluate the effects of PEM brought on by the 10-minute NASA Lean Test. Our results showed no change in UpTime after the NASA Lean Test. Although this contradicts our expectations, we have confirmed that the 10-minute NASA Lean Testis humane; patients with ME/CFS do what they can to avoid stress-causing exertion, but we have seen that this test does not cause a drastic decrease in UpTime—indicating that diseased subjects aren’t significantly hurt by the test.

 

[MEMarge]

I have been surprised by the number of people with ME, yet not necessarily POTS who find sitting with their feet up much less tiring than having them on the ground.

 

[Hoopoe]

Although it varies, in the last week I have spent relatively little time in horizontal position and still consider myself seriously impaired.

I've had periods of >50% time spent in bed too. I don't think the difference between these bad and the current good period can be adequately measured in terms of time spent with feet on the floor.

I would be LESS ill if I spent more time in bed resting. I just can't bear the boredom. If I could keep myself entertained in bed I would probably spend more time in bed.

 

[butter.]

this gets us nowhere.

 

[wigglethemouse]

I don't get all the negativity. This is a pilot study. As far as I'm aware this is the first time some has tried to objectively show orthostatic intolerance is a major symptom affecting quality of life. Many believe it just affects those with POTS and that is not the case.

With a tool like this you could take Systroms studies and see if there is a correlation between upright time and small fiber neuropathy tests, or other objective tests. In a Workwell CPET test it might give more objective info about the effect PEM. It shouldn't be expensive to implement.

 

[Trish]

I think it is a useful measure specifically for OI, rather than for ME overall. Given that OI of various types seems to be accepted as one of the symptoms of ME, that's a good step forward. I agree with others that it's not the whole story. I think any treatment trial wanting objective outcome measures would need a combination of tests, for example a combination of uptime, step count and cognitive tests.

 

[Invisible Woman]

I don't get all the negativity.

I'm not negative about it. It's something that could be very useful. I think it's important that we don't overstate what something can do or results can show.

We have to be as objective & critical about this as about a BPS paper that makes a claim that goes beyond what their data show.

 

[wigglethemouse]

They used Shimmer and VICON inertial measurement units and then applied their own algorithms to extract the data on upright time.
VICON datasheet (Blue Trident?): https://www.vicon.com/hardware/blue-trident/
Shimmer (Schimmer 3?) : https://www.shimmersensing.com/products/shimmer3-imu-sensor

The Excel data doesn't seem to be available yet.

Filename: Additional file 1
File Format: .xls
Description of data: This excel file includes the data collected throughout the case-control study. All statistical tests reported in this article were created using the data contained in this file.

With a tool like this you could take Systroms studies and see if there is a correlation between upright time and small fiber neuropathy tests, or other objective tests. In a Workwell CPET test it might give more objective info about the effect PEM. It shouldn't be expensive to implement.

I wonder what it would take to build an app to communicate with these devices or the data that they generate such that it could be used by other researchers for their studies? Or will this end up an interesting avenue that doesn't get followed up due to funding?

 

[Hoopoe]

I think activity measurement could be more accurate than time spent upright, although still flawed due to the inability to detect cognitive exertion and symptom burden.

 

[wigglethemouse]

I think activity measurement could be more accurate than time spent upright, although still flawed due to the inability to detect cognitive exertion and symptom burden.

They used inertial measurement units strapped to the leg so in theory activity can be measured at the same time. I wonder if they can extract that data too from the raw data they have and what it would show...........

 

[Hoopoe]

I also believe that orthostatic intolerance is generally only recognized after a certain severity, when there begins to be an obvious connection between being upright and feeling worse. The underlying problem that causes the orthostatic intolerance can perhaps exist long before this point and continue to cause various vague symptoms throughout the day as the effect of sitting and being upright accumulates.

The body will try to compensate by releasing adrenaline and noradrenaline and these will make you feel unwell. They might also be the reason why people tend to overexert, because these hormones make you want to keep going. At least until the symptoms reach a point where it's just too stressful.

 

[InitialConditions]

Other than the last sentence of the conclusion, which seems a bit odd, it does seem useful.

"With the added perspective of large-scale studies, this sensor-based platform could provide a recovery path for individuals struggling with ME/CFS."

I hope it means something like "this could be a useful objective measurement of physical activity, in trials of therapies for ME..."

ETcorrect: typo

There's a myth in our community that we'd all recover under the right circumstances - avoiding PEM, stressors, being able to rest at all times when needed.

 

[Amw66]

It's refreshing to read a paper where they discuss their failure to prove their hypothesis that the NASA 10 minute lean test would induce PEM and that that would be detectable by upright activity.

Depends over what time period they looked to correlate this.