F117 How Music Beats Got a Breakthrough Device FDA Designation (Brian Harris, MedRythms)

Music can change our mood, energize us, make us feel invincible. It goes beyond that: it can heal.

MedRythms is a digital therapeutics company building direct stimulation solutions that use clinical-grade sensors, AI-driven software and music to help restore function lost to neurologic disease or injury. Last year, the company received a Breakthrough Device designation from the FDA for its patented digital therapeutic that treats chronic stroke walking deficits. MedRythms is also doing Randomized Control Trials in multiple indications, including stroke, MS, Cerebral Palsy, and Parkinson’s Disease.

Where does the power of music come from?

The research about the health effects of music has been developing in the last 20 to 30 years, through the advancements of neuroimaging and neuroscience.

Brian Harris.

MedRythms is focused on the impact of music and specifically rhythm, to engage the motor system to improve walking and improve movement. As explained by the CEO Brian Harris, in the mid 1970s the seminal works in the field showed that you could use rhythm to engage the motor system, because of how our auditory and motor systems are connected in the brain. By the early 2000s technology has finally caught up with our ability to understand physiological and neurological processes.

Before founding MedRythms, Harris was a clinician at the Spaulding Rehabilitation Hospital in Boston, where he worked as a Board Certified music therapist with advanced training in the neuroscience of music. “We used rhythmic auditory stimulation, which is a standardized intervention based upon the neuroscience of rhythm and how rhythm can engage the motor system to improve walking. We saw in practice how when stroke patients with walking deficit walked to rhythm, their quality of walking improved,” explained Harris.

The scientific proof

“In the beginning, clinical research was focused on how rhythmic auditory stimulation could improve functional outcomes. Speed, symmetry, stride length, were studied in the early 1990s and it was demonstrated that rhythm has a profound effect in outcomes in stroke and Parkinson's disease. In recent years, those studies have been replicated in cerebral palsy, in traumatic brain injury in multiple sclerosis and in the aging population as well,” elaborates Brian Harris. The field is gaining a rich understanding of the deeper neural perspective. “Recent research shows how rhythmic auditory stimulation can impact dopamine. What we know about dopamine is that it's important for movement specifically in individuals with Parkinson's disease. One of the consequences of Parkinson's disease is a dopaminergic deficit. It's been shown that rhythmic auditory stimulation can from a chemical perspective actually impact dopamine,” says Harris. The impacts of improved motor skills in these patients can be significant. “We know that people suffering from neural disease are often rehospitalized because of injuries due to falls. When people fall and break a hip the cost is between 30 to $50,000. If we can improve walking we actually have an impact on falls.”

The broader picture

Listening to music goes beyond just the healthing effects. “Playing music also impacts neuroplasticity, it creates the healthy brain, it creates stronger connections in the healthy brain,” emphasized Harris, who believes this should be recognized on a societal level. “If administrators and legislators understood what we know now about how music can be used to improve outcomes, they would never dream of cutting a music program in education because it's that important. It's been shown to have correlations to improve education outcomes and improved mental health outcomes.” Music is important to human beings across the lifespan, and regardless of age, or culture, or ability, or disability. But we really need to be thoughtful and purposeful about how we use music in a medical way to improve outcomes, said Harris.

Some questions addressed:

Different music makes us feel differently. How did you dive into the field of the power of music on health? 

• A number of studies have shown that rhythmic entrainment of motor function can actively facilitate the recovery of movement in patients with stroke, Parkinson’s disease, cerebral palsy, and traumatic brain injury (Thaut, 2005), the potential applications of music therapy in patients with neuropsychiatric disorders, including autism spectrum disorders, albeit intuitive, have led to psychotherapeutic uses aimed at directly evoking emotions.

• The link between music and emotion seems to have been accepted all time. But not so much for the treatment of physiological problems. When and how did this change? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5618809/ 

• What triggered your thinking about using the power of music to impact the mobility of patients with neurological conditions? 

• So let’s dive deeper: what exactly does MedRhytms does? How does it work? You receive a Breakthrough Device designation from the FDA for your patented digital therapeutic that treats chronic stroke walking deficits – where this is currently no standard of care. 

• The solution will be released in 2021. How many patients are already in line or predicted to receive the treatment? 

• How does music therapy differ from conventional therapy in its efficacy? 

• The reason our innovation works is rhythm. To which extent is the music personalized for a specific patient? 

• Is it possible for individuals to encourage the positive effects of music (meant in a medical sense)? If yes, how? 

• Given all we’ve said, is there  any advice you might have for all of us regarding what kind or how we should listen to music?