Clinical Trials & Research News

MedRhythm Begins Trial to Study Digital Therapeutics for Stroke

In partnership with UMass Memorial Healthcare, the trial studying digital therapeutics for stroke will be split in two phases, one in the hospital setting and one post-discharge.

Digital Therapeutics

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By Samantha McGrail

- Digital therapeutics company, MedRhythms, recently announced the launch of a clinical trial to study the company’s digital therapeutics trial for stroke, MR-010.

In partnership with UMass Memorial Healthcare, the trial will be split into two phases and examine the eligibility of MR-010 to address the walking impairments in individuals in the acute phase of stroke. 

The first phase will look at the impact of MR-010 within the acute hospital setting, while the second phase will examine the continued impact of the therapeutic post-discharge. 

"We are honored to be collaborating with the nation's leading researchers and institutions to build the evidence necessary to bring important care to all those who need it," said Brian Harris, the CEO and co-founder of MedRhythms. 

"Strokes have devastating effects on mobility, which significantly impacts independence and quality of life. We look forward to making a positive impact on these patients throughout their entire recovery journey,” Harris continued.

Stroke is the top cause of long-term disability globally and over one-third of stroke survivors live in the US. According to the CDC, nearly 800,000 individuals in the US suffer from a stroke each year. 

Digital therapeutics as a potential treatment option enables the “early verticalization” of patients and is more effective when compared with other therapies alone. Overall, these therapies can improve motor function for individuals, MedRhythms stated. 

The company believes it is designed to meet this unmet need by validating the efficacy of MR-010 in clinical trials. 

"Given the prevalence and profound impact of walking deficits on stroke survivors, we are excited to be a part of investigating a promising new intervention in the acute stroke setting that could change the trajectory of rehabilitation for stroke patients," said Brian Silver, interim chair in the department of neurology at UMass Medical Memorial Healthcare. 

Back in 2019, MedRhythms added a stroke scientific advisory board to develop digital therapeutics. The therapeutics use sensors, software, and music to support gait rehabilitation in adults suffering from neurological injuries or diseases. 

The Scientific Advisory Board strengthened MedRhythms' experience and knowledge in the areas of stroke research and recovery. The establishment is part of the company’s efforts to better serve stroke survivors by understanding them on a deeper level. 

The first digital therapeutic MedRhythm developed focused on addressing walking deficits in the post-stroke population. 

Therefore, later that year, the company launched its five-site randomized controlled trial to study the first product in the company’s pipeline of digital therapeutics for neurological disease and injury.

The trials examined the therapeutic’s impact on walking among a group of subjects who are stroke survivors with post-stroke walking impairments. 

The trials will be conducted at the nation’s top rehabilitation hospitals and research centers, including the Shirley Ryan AbilityLab, the Kessler Foundation, Mt. Sinai Hospital, Spaulding Rehabilitation Hospital, and the Boston University Neuromotor Recovery Laboratory. 

David Putrino, director of Abilities Research Center (ARC) for the department of rehabilitation and human performance at the Mount Sinai Health System stated that MedRhythms digital therapeutic technology is a novel treatment for a subset of individuals that have few effective treatment options.

The therapeutic for post-stroke walking rehabilitation is one of many products that include therapeutics for indications including Parkinson’s Disease, Multiple Sclerosis, aging, and fall prevention. 

Currently, MedRhythm is actively exploring partnerships to expand its therapies pipeline.