A small group of people with Parkinson’s disease adhered well to an experimental music-based digital therapy to treat gait problems, and reported quality of life gains, meeting the main goals of a small feasibility trial, according to its developer MedRhythms.
Preliminary evidence of the trial (NCT04891107) that included 24 patients also suggested improvements in motor function and mobility after a month with the MR-005 platform, which seeks to synchronize a person’s walking pattern to musical rhythms.
“In successfully completing our first clinical trial in Parkinson’s disease … we have made significant progress on the advancement of our pipeline,” said Brian Harris, CEO and co-founder of MedRhythms, in a company press release.
MedRhythms plans to submit trial results for publication to a peer-reviewed journal and present them at an upcoming scientific conference.
“The results from this study related to adherence and early signals of clinical improvements with Parkinson’s disease patients are compelling and suggest that this could be a promising intervention for improving gait deficits in this population,” said Terry Ellis, PhD, one of the trial’s principal investigators, and an associate professor and chair of the department of physical therapy at the Boston University College of Health & Rehabilitation Sciences: Sargent College.
A follow-on clinical trial, called Amped-PD (NCT05421624), is underway and is testing MedRhythms’ platform against a regular walking program among 44 adults with Parkinson’s.
Benefits of rhythmic auditory stimulation
MedRhythms’ technology utilizes the principles of rhythmic auditory stimulation (RAS) to improve persistent walking difficulties. Given that certain brain pathways involved in movement play a role in auditory processing, RAS works to entrain, or synch up, these processes using an external auditory cue. In other words, to coordinate a person’s own walking speed and rhythm with the musical beat they hear.
It’s believed that this entrainment promotes neuroplasticity, or the process by which the brain adapts and rewires in response to new experiences, which might lead to sustained improvements in mobility.
MedRhythms’ patented digital therapeutics platform is based on three decades of research indicating that RAS-based therapies can improve walking impairments in people with neurological diseases and injuries, according to the company.
Sensors are worn on a person’s shoes to collect gait information that’s then analyzed using proprietary software on a smartphone app. The algorithm uses that information to develop a customized audio intervention, employing rhythms thought to be most beneficial for that person. Music is selected from a library that’s been pre-screened and determined to be therapeutic.
The feasibility study, announced in 2021, recruited 24 adults with Parkinson’s who were able to walk independently without assistance at two U.S. sites.
The participants were instructed to walk at home or in their neighborhood using the wearable sensor system — foot sensors, a smartphone with a mobile app, and headphones — for 30 minutes, five times a week over four weeks.
The trial’s main goals were to assess adherence to the therapy schedule and its impacts on mobility-associated quality of life. Top-line data indicated both goals were met.
Preliminary data relating to secondary outcomes also showed gains after four weeks, including improvements in walking capacity and functional mobility and reduced motor symptoms, the company reported.
In addition to MR-005, MedRhythms’ pipeline includes experimental programs for multiple sclerosis, chronic stroke, post-acute stroke, functional neurological disorder, aging, and cognition. This month, the company announced a pivotal trial of MR-001 improved gait speed in adults recovering from a stroke, meeting its main goal.
“The clinical feasibility from this trial and our recently completed pivotal trial in chronic stroke is essential as we work toward our goal of building next-generation neurotherapeutics that are evidence-based and can positively impact the lives of patients around the world,” Harris said. “As MedRhythms works to create a world where everyone with neurologic injury and disease has access to the highest quality care, it’s essential that we make progress on the research and development of our pipeline across a range of neurological conditions.”