Clinical Trial of Rhythmic Sound in Walking Rehab for MS Planned, MedRhythms Says

MedRhythms is planning to soon open a pilot clinical trial to assess the safety and efficacy of its MR-004, its investigational product that uses rhythmic sounds to improve walking abilities in people with multiple sclerosis (MS), the company announced.

The randomized and controlled trial, fully support by a grant from the Consortium of Multiple Sclerosis Centers (CMSC), will be conducted at the Cleveland Clinic.

MedRhythms is a digital therapeutics company exploring the use of sensors, software, and music to aid in walking rehabilitation.

More than 50 clinical research studies have reported improvements in movement based on the use of rhythmic auditory stimulation through music, the company reports.  These studies were conducted in people with diseases or conditions affecting the brain, including MS, Parkinson’s disease, cerebral palsy, and stroke.

Rhythmic auditory stimulation directly stimulates the brain to activate a mechanism known as “entrainment” — a neurologic process in which the brain’s auditory and motor regions are coupled, MedRhythms states on its website. Entrainment can enhance neuroplasticity (the brain’s ability to strengthen pre-existing neural connections, allowing a person to acquire skills over time), and induce neuroplastic changes that produce improved motor outcomes.

Music, the company proposes, induces the neurological connections needed for the positive re-wiring of the brain.

MR-004 is the company’s pipeline product, based on rhythmic auditory stimulation, being developed for walking rehabilitation in MS.

“I’ve conducted many trials on interventions to improve walking in those living with MS, including the compelling impacts of rhythmic cueing in this population,” Francois Bethoux, MD, a paid advisory member to MedRhythms and who will lead the trial, said in the press release.

“I look forward to undertaking the role of principal investigator in this study, and to learn more about this investigational therapy and its potential impact on mobility and quality of life in patients with MS,” Bethoux added.

MedRhythms also announced the creation of Scientific Advisory Boards (SABs) to help direct the company’s clinical and research activities in the areas of MS and Parkinson’s disease.

Members of the company’s scientific board for its MS programs include Bethoux, the director of rehabilitation services at the Mellen Center for Multiple Sclerosis at Cleveland Clinic, and John DeLuca, PhD, the senior vice president for research and training at the Kessler Foundation and a professor at Rutgers New Jersey Medical School.

Members of its Parkinson’s SAB include Bastiaan Bloem, MD, PhD, a co-director for Parkinson’s Net and scientific advisor to Michael J. Fox Foundation; Ray Dorsey, MD, MBA, director of the center for Health Technology at the University of Rochester; and Alexander Pantelyat, MD, director of the Atypical Parkinson’s program at Johns Hopkins and director of the Johns Hopkins Center for Music and Medicine.

“We are excited to advance the pipeline of products by adding these world-renowned researchers and clinicians to our MS and PD [Parkinson’s disease] Scientific Advisory Boards,” said Brian Harris, co-founder and CEO of MedRhythms.