FDA lists platform using rhythm to aid walking as Class II device
MedRhythms' MR-005, called Movive, soon available in select US markets
The U.S. Food and Drug Administration (FDA) has listed MR-005, MedRhythms’ digital therapeutic platform using rhythmic beats to help with walking in Parkinson’s disease, as a Class II device requiring medical prescription.
A Class II medical device is associated with a moderate to high risk to patients, and is subject to controls by the FDA that can include post-market surveillance.
The company expects to launch MR-005, under the brand name Movive, in select U.S. markets in the coming months.
“This is an exciting step for MedRhythms as we advance our mission to use music to address significant mobility challenges for people with neurologic injury and disease, including [Parkinson’s disease],” Brian Harris, co-founder and CEO of MedRhythms, said in a company press release. “We look forward to Movive’s potential to support gait rehabilitation in [Parkinson’s disease], addressing a significant need.”
Rhythm is thought to engage the brain in ways that help with movement
Parkinson’s is caused by the progressive dysfunction and death of dopaminergic neurons, the nerve cells that produce dopamine — a brain signaling molecule involved in motor control. Dopamine’s loss leads to problems in nerve signaling and to the disease’s motor symptoms, including walking impairments.
Research has shown that music can activate areas of the brain responsible for movement, and that rhythm can engage the motor system in ways that can help with walking, the company reports. This is associated with the connectivity between motor and auditory brain regions, allowing these systems to synchronize to an external auditory cue.
MedRhythms reports that its technology utilizes the principles of rhythmic auditory stimulation (RAS) to promote entrainment, the process by which motor and auditory systems synchronize and coordinate a person’s walking speed and gait to the rhythm they are hearing. This process is thought to enhance neuroplasticity, or the brain’s ability to adapt and establish new nerve connections in response to new experiences, potentially allowing for sustained improvements in mobility.
Its platform combines sensors placed on a patient’s shoes to capture information on gait in real time, which is then analyzed by the company’s proprietary software on a smartphone app. Data is used by the algorithm to deliver a personalized rhythm believe to be beneficial for that person.
Music is selected from an audio library determined to be therapeutic, encouraging patients to walk to the beat being played. The algorithm constantly assesses the user’s walking ability, and adjusts the auditory stimuli to help the person to progress.
The platform’s preliminary efficacy was assessed in a pilot clinical study (NCT04891107) in about 24 people with mild to moderate Parkinson’s, who used the Movive system for about one month (four weeks) while walking for 30 minutes five times a week around their home or neighborhood.
Results showed that patients adhered well to treatment, with most completing the trial’s 20 total walks using the system. Participants reported gains in quality of life, and improvements in their walking capacity and functional mobility.
MedRhythms’ pipeline also includes programs for multiple sclerosis, chronic and post-acute stroke, functional neurological disorder, aging, and cognitive issues.
About the Author
