Home-based actigraphy to predict change in neurological function in multiple sclerosis
Principal Investigator: Ellen Mowry, M.D.
This study is testing if wrist-worn activity monitors, called Actigraphs, can be used to measure subtle changes in functioning in people with multiple sclerosis.
Why is this study important?
The Expanded Disability Status Scale (EDSS) is the current gold standard for identifying changes in functioning caused by multiple sclerosis (MS), but it has many faults. EDSS assessments may not indicate changes in functioning early in their development, and the scale becomes less sensitive to change as disability increases. Because of this, measuring change in function and disability in the later-stage, progressive form of MS is challenging. To overcome this challenge, this study aims to prove the utility of actigraphy, a method for monitoring rest and physical activity, in identifying small changes in disability in people with MS. Having a more sensitive measure of disability change will allow doctors to react faster to worsening disability and will accelerate research developing new treatments for progressive MS.
What are the study’s goals?
Goal 1:
Validate actigraphy as a tool for measuring disability change by confirming actigraphy measurements show disability worsening in people with MS already known to have disability worsening.
Goal 2:
Evaluate if actigraphy can distinguish changes in disability faster than traditional methods of disability measurement.
Goal 3:
Quantify how much actigraphy measurements contribute to identifying changes in disability when combined with traditional methods of disability measurement.
What is an Actigraph?
Actigraphs are wrist-worn devices that continuously gather activity measurements. Actigraphy data can be used to interpret the quality and duration of wearers’ sleep, as well as follow peaks and wanes in wearers’ physical activity. Actigraphs are already being used to quantify impairment from aging, identify disruptions in the daily sleep-wake cycle in people with mood disorders and Alzheimer’s, and quantify frailty and fatigue in people with heart disease. We believe actigraphy measurements can also be used to identify changes in disability in people with MS.
What do we know so far?
Our preliminary research has demonstrated that actigraphy has the ability to distinguish between people with different levels of disability. Actigraph data displayed in the graph below showed that higher EDSS scores were associated with less daily activity, and that this association was strongest during the afternoon and evening between 12:00 P.M. and 7:30 P.M.
Our preliminary data has also shown that activity measurements change if disability worsens. Comparing actigraphy data from the beginning of the study to data from a year later showed that people with worsening EDSS scores also had lowered activity and greater variability in activity on a day-to-day basis (shown in box plots).
Additionally, changes in activity were noticeable even in people whose EDSS scores did not change after a year. Furthermore, those who entered the study with a high EDSS score (which may suggest higher risk for transitioning to progressive MS) showed changes in activity that differed compared to those entering with a low EDSS score (shown in red and blue line graph). These findings support that activity measurements may be more sensitive to disability change than EDSS, especially in people with greater disability.
What is the study’s timeline?
Participation in this study lasts up to a total of 4.5 years, beginning with an in-person visit. At all in-person visits, traditional measurements of disability are assessed, and each participant is supplied with an Actigraph to wear for the next two weeks. While in-person visits occur every 6 months, Actigraphs are to be worn every three months. When participants aren’t coming in for a visit, Actigraphs are shipped to them.
