MedRhythms Launches Trial of Rhythmic Sound Therapy to Aid Walking

The digital therapeutics company MedRhythms is launching a clinical trial to evaluate the safety and efficacy of MR-004, an experimental product that uses rhythmic sounds to improve walking abilities in people with multiple sclerosis (MS).

The randomized and controlled trial, funded by the National Multiple Sclerosis Society, will be conducted in collaboration with Massachusetts General Hospital (MGH), the company announced in a press release.

Studies show that over 80% of people with MS have a walking impairment, like a slower speed and poorer quality of walking. This happens because the immune system erroneously launches an  attack against the fatty sheath covering nerve fibers (myelin) that transmits electrical signals throughout the body, ultimately impacting movement.

Improved walking quality and speed are tied to personal independence, which promotes a better quality of life. Research has demonstrated that every 0.01 meter per second increase in walking rate corresponds to a 7% lower risk of falling, MedRhythms stated in its release.

MR-004 is a therapeutic application of pulsed rhythmic or musical stimulation called rhythmic-auditory stimulation (RAS). It is thought that RAS activates the brain via a neurologic process known as entrainment, in which the auditory and motor systems are coupled by external rhythmic cues.

Evidence suggests RAS can synchronize walking patterns, quickly leading to improvements in stride time, stride length, and symmetry.

“Previous studies have demonstrated the positive impacts of Rhythmic Auditory Stimulation on gait training in people with multiple sclerosis, and this study is an exciting advancement of these previous clinical trials,” said Brian Harris, CEO of MedRhythms. “As a new treatment in healthcare, it is important that rigorous evidence be developed to support the intervention.” 

Participants in the trial will be randomly assigned to MR-004 or standard of care alone. After a period of time, patients given MR-004 will return to standard of care only, and while those previously on switch to try MR-004. 

The potential therapy uses sensors placed on the shoes to detect walking gait, and relays that information to a smartphone app, changing the music to match rhythm in real-time. The music has been prescreened for therapeutic use, enabling a wide range of user-preferred content. 

In addition to functional outcomes, the study will use MRI scans to measure brain activity and assess the impact of MR-004 on MS participants.

“Looking at the underlying functional connectivity via MRI will shed new light onto the understanding of Rhythmic Auditory Stimulation and its applications for gait training in multiple sclerosis,” said Eric Klawiter, MD, study co-principal investigator at MGH.

This study expands on a clinical trial evaluating MR-004 in MS at the Cleveland Clinic announced in 2020. MedRhythms also recently announced a study testing the similar product, MR-005, in people with Parkinson’s disease.