The trial will be the first neuroimaging study aimed at observing the impacts of rhythmic auditory stimulation on walking impairment in multiple sclerosis.
Eric Klawiter, MD, MSc
According to a recent announcement, digital therapeutics company MedRhythms is collaborating with Massachusetts General Hospital (MGH) on a neuroimaging study that will assess MR-004, MedRhythms’ multiple sclerosis (MS) asset.1
Funded by the National Multiple Sclerosis Society, the groundbreaking trial will be the first neuroimaging study to examine the impact that rhythmic auditory stimulation (RAS) has on walking impairments in patients with MS. MR-004, a digital therapeutic that uses rhythmic sounds, will be evaluated in a randomized crossover trial that will assess outcomes including gait speed and neuroimaging compared to the standard of care.
The study will be led by co-principal investigators Eric Klawiter, MD, MSc, director, Multiple Sclerosis and Neuromyelitis Optica Unit, MGH, and Ron Hirschberg, MD, assistant professor of physical medicine and rehabilitation, Harvard Medical School. “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,” Klawiter said in a statement.1
The study expands on a pilot study that is assessing the safety and efficacy of MR-004 in patients with MS at Cleveland Clinic, which was announced in January 2020.2 Made possible by a grant from the Consortium of Multiple Sclerosis Centers (CMSC), that study is led by MedRhythms MS Scientific Advisory Board (SAB) member Francois Bethoux, MD.
Walking impairments are common in patients with MS, occurring in over 80% of cases. To date, there have been over 50 clinical research studies demonstrating improvements in movement when using RAS.3
Walking speed is also highly correlated with fall risk. A study led by Joe Verghese, MD, MS, and colleagues showed that each 0.1 m/s increase in walking speed correlates to a 7% decrease in fall risk. Additionally, participants in the study with slow gait speed (≤70 cm/s) had a 1.5-fold increased risk for falls compared to those with normal walking speed.4
"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," Brian Harris, chief executive officer, co-founder, MedRhythms, said in a statement.1 "As a new treatment in healthcare, it is important that rigorous evidence be developed to support the intervention. We are excited to be advancing the science that supports rhythmic auditory stimulation and digital therapeutics as we enter into this novel and important study."
MedRhythms also recently announced the initiation of a clinical trial evaluating MR-005 in patients with Parkinson disease (PD).5 MR-001, MedRhythms’ patented digital therapeutic to treat walking deficits associated with chronic stroke, received breakthrough designation in June 2020 and is currently being assessed in a randomized clinical trial across 5 US rehabilitation sites.