“Defining the Postural Contributors to Post-Exertional Malaise (PEM) in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”
Principal Investigator: Shad Roundy (PhD)
University of Utah
Collaborators: Lucinda Bateman (MD), Turner Palombo, Andrea Campos
Shad Roundy, PhD, a highly accomplished engineer from the University of Utah, and graduate fellow Turner Palombo will validate whether a wearable sensor device worn on the ankles accurately measures the amount of time spent in an upright posture and whether this reflects ME/CFS disease severity. Working with his co-Investigator, Dr. Lucinda (Cindy) Bateman, and Andrea Campos, measurements will be taken at baseline and after provoking post-exertional malaise (PEM) in a group of moderate to severe patients. The results will be compared with control subjects. If successful, this proposal could result in a clinical endpoint for disease severity that would significantly impact ME/CFS research and clinical practice.
“The Bateman Horne Center, through years of observations, has identified a simple, yet effective method to measure ME/CFS disease severity. And, as it turns out, my expertise in motion based micro-sensors can be useful in implementing this method. As a mechanical engineer, it is quite exciting for me to be able to use my expertise toward a significant health problem that affects so many people, and yet is so little understood. Having had a close friend that suffered from ME/CFS for years, it is particularly rewarding for me to work toward methods that could result in treatments to improve her life.” — Shad Roundy
“I am enthusiastic about the opportunity to help guide the development of a novel research tool that can objectively capture a core feature of MECFS—impaired function—and effectively measure clinical trial outcomes.” — Cindy Bateman
Read the research team’s study abstract below:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating disease that affects as many as 2.5 million people in the U.S. At least one-quarter of ME/CFS patients are house- or bedbound at some point in their lives. The economic impact of ME/CFS is $17 to $24 billion annually for direct costs and $9.1 billion from lost household and labor force productivity.
There are no FDA approved treatments for ME/CFS. In 2013 the FDA Center for Drug Evaluation and Research held a workshop to expedite the development of safe and effective drug therapies for ME/CFS. The meeting transcript noted that ME/CFS was not on the pharmaceutical industry radar due to a lack of valid, reliable, and measurable efficacy endpoints. Efficacy endpoints are measurable outcomes that test the health benefit of an intervention in a clinical trial. The FDA’s guidance document for developing drug products for the treatment of ME/CFS suggested using reliable instruments to measure patient-reported symptoms as well as objective measures as efficacy endpoints to quantitatively measure health benefit. An example of an objective efficacy endpoint for ME/CFS would be increasing the period of time one is able to sit upright, stand or walk, with the ability to objectively demonstrate the improvement.
Post-exertional malaise (PEM) is the cardinal symptom of ME/CFS. As the phrase suggests, PEM is the overwhelming feeling of weakness, heaviness and flu-like illness that occurs following physical and mental exertion. Patients report PEM can be triggered by the most mundane of daily activities including sitting upright at the dining table, socializing, standing, taking a shower, and driving a car. Upright posture with feet on the floor is a consistent feature of all PEM-inducing activities. Both clinical observations and pilot studies have indicated that less time in an upright posture, with feet on the floor, over a 24-hour period corresponds with ME/CFS disease severity. This observation points to hours of upright posture as a measurable and potentially powerful efficacy endpoint to demonstrate the effectiveness of pharmaceutical and non-pharmaceutical treatments.
The goal of this project is to develop and demonstrate an objective measure of upright posture using recent advances in wireless sensing devices. Specifically, we will use two wireless motion sensing units attached to each lower leg to detect when a person is upright with feet on the floor. The motion sensing units measure acceleration and rotation in 3 directions. Similar sensors are in mobile phones and fitness trackers and are used to determine things such as which direction is up so the display can automatically rotate, or how many steps the wearer of a fitness tracker takes. We will use similar wearable sensors along with existing and custom created algorithms to determine the amount of time a person is in an upright position.
We will then use these wearable sensors in a pilot study to determine their ability to differentiate between people who exhibit severe, moderate, or no ME/CFS symptoms. Study participants will wear the sensors for 72 hours to create a baseline. They will then be subjected to a laboratory test (10-minute NASA lean test) that induces PEM thereby affecting subsequent hours of upright posture. Study subjects will then wear the sensors for another 72 hours after the test. We hypothesize there will be a change in amount of time ME/CFS patients are in an upright posture because of the test-induced PEM.
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.