Music as medicine: FDA approves stroke damage therapy from Portland startup

Music as medicine: FDA approves stroke damage therapy from Portland startup Hannah LaClaire

Brian Harris is a co-founder and CEO of MedRhythms, a Portland startup that uses sensors, software and music to help people with brain injuries recover their ability to walk. Gregory Rec/Staff Photographer

Doctors soon may start writing an unconventional prescription to help stroke survivors regain their ability to walk: music.

MedRhythms, a Portland medical technology startup, has gotten the green light from the Food and Drug Administration to market the company’s neurorehabilitation system, InTandem.

The system uses sensors, software and music to help people who have suffered brain injuries recover their walking ability. InTandem is now designed to help chronic stroke survivors. But feasibility studies have shown promising results for similar therapies that might someday treat patients with Parkinson’s disease and multiple sclerosis.

At its core, the technology is based on the neuroscience of how rhythm engages parts of the brain responsible for movement, said Brian Harris, MedRhythms co-founder and CEO.

Often, people who have experienced strokes require physical therapy to help restore muscle function. Over the years, studies have shown that neurologic music therapy also can be used to improve the speed and stability of a patient’s gait, improve balance and reduce the risk of falling down.

Harris, a board-certified music therapist and one of only a few hundred neurologic music therapists in the world, has been entrenched in this science for years. He saw first-hand the power of neurologic music therapy while working at Spaulding Rehabilitation Hospital in Boston, and wanted to make that therapy available to more people.

The FDA listing – the agency’s term for approval of certain medical devices – is a major step in making that happen. The listing eventually will allow for widespread marketing of the system.

“I am honored and proud that our team has committed to our mission of translating these (medical) interventions into evidence-based medical devices that can be utilized in home settings, breaking down several historic barriers to access,” Harris said in a statement.

THE SCIENCE OF RHYTHM

An app was the logical choice. But Harris and Owen McCarthy, co-founder and president, wanted to make sure it wasn’t just another option in an app store. The therapy needed scientific rigor.

“We’re treating patients that have disabilities,” Harris said. “We’re talking about real, severe medical conditions.”

In traditional physical therapy, the standard approach is to get the patient mobile and to try a specific movement – for example, attempting to move a leg – over and over and over again. But each time, they’re essentially starting from scratch, said Dr. Frank Willard, a neuroanatomy professor at the University of New England in Biddeford.

Music therapy though, introduces rhythm, which can help with other rhythmic movements like speech, swallowing, or, in this case, walking.

That’s because the brain areas involved with music are also active in processing language, auditory perception, attention, memory, executive control and motor control, according to the Dana Institute, a neuroscientific philanthropic organization.

“The individual has suffered significant damage in their brain. They have lost pathways that will get into the motor system to trigger (movement),” Willard said.

So when music is played, that rhythmic activity that goes through the auditory system bypasses the damaged part of the brain and goes through those shared neural pathways, he said.

MOVE TO THE BEAT

The concept for InTandem is relatively simple, even if the science behind it is not.

Patients download an app loaded with MedRhythm’s software and music, connect a sensor to their shoes, plug in their headphones and start walking.

The sensor measures the patient’s walking characteristics and cadence, and adjusts the tempo of the music, as needed.

The change in tempo triggers a subconscious neurological response that helps the patient walk faster and more easily. Through repeated use, it’s been shown, the brain can be rewired to facilitate better walking even when there is no music.

When humans – regardless of whether they’ve had a stroke or other neurological impairment – hear a rhythm, the brain begins predicting when the next beat is going to “hit.” The motor and auditory systems subconsciously synchronize, said Dr. Lou Awad, director of the Neuromotor Recovery Lab at Boston University.

If you watch someone listen to a song with a good beat, they’ll frequently start to drum their fingers or tap their feet to the music, even without meaning to.

This auditory-motor entrainment (the coordination between the two systems) doesn’t require music. The same thing happens when you hear a metronome, Awad said.

But MedRhythms makes the process more interesting.

And it’s not just a generic, rhythmic, driving beat. MedRhythms has partnered with Universal Music, the world’s largest music group, to access its entire library of songs, from ABBA to Wu-Tang Clan. Rock fans can listen to rock music, and pop fans can listen to pop, and the software will take it from there.

And according to Willard, being familiar with the beat of the music makes those predictions easier and often leads to better outcomes.

Awad, whose lab was one of the locations for MedRhythms’ clinical trials, said the ability to select their own music will help patients stick with the therapy.

“They will want to do this, which is very different from ‘they have to do this,’ ” he said.

‘OPENING THE FLOODGATES’

Awad said he also is encouraged by how the same principles guiding InTandem can be adapted for patients with Parkinson’s disease and multiple sclerosis, or right after an acute stroke.

While the general idea is the same, Willard said music therapy could be a powerful tool for Parkinson’s in particular.

“The brain has a variety of ways in which it tries to rebuild after an injury, but in a degenerative disease, it’s different,” he said. “You’re losing some of the capacity for some of that plasticity.”

But it can still help.

One of the problems Parkinson’s patients face is gait continuity, Willard said – stopping or getting started again. Music therapy has shown it can increase cadence and improve the initiation of movement.

Beyond just walking-based therapy, music therapy also can potentially help patients who struggle with language, particularly after a stroke.

“There’s a whole world that I know can benefit from this kind of therapy,” Awad said. “MedRhythms is opening the floodgates. It’s not the end. It’s the beginning of this kind of work.”

AN UNMET NEED

The company has received several rounds of venture capital funding and has to date raised $42 million in private financing.

InTandem launched its clinical trials in 2019 and received Breakthrough Device Designation from the FDA in 2020. A pivotal clinical trial was completed this year.

Harris said the FDA listing the product is a historic milestone not just for MedRhythms, but also for health care, music, and especially, for stroke survivors.

InTandem has the potential to address a huge unmet need, he said.

Every year, more than 795,000 people in the United States have a stroke, according to the U.S. Centers for Disease Control and Prevention. Stroke is a leading cause of long-term disability in the U.S., and over half of people 65 or older who have had a stroke experience reduced mobility and gait deficits.

The concepts behind InTandem, rhythmic auditory stimulation, and rhythmic auditory-motor entrainment, have been studied for decades. Physical therapy and music therapy for stroke survivors also is nothing new. But historically, patients have needed to work with a clinician trained in RAS and there were never enough.

The challenge always has been access, Awad said. But since MedRhythms is used at home via smartphone, the technology can be used anywhere.

It’s also essentially risk free.

“You don’t have to worry about hurting somebody with it, which is really significant,” Willard said. “With a lot of other therapies, you run risks.”

Harris was tight-lipped about the specifics of the impact of the FDA approval. He could not say how much the device would cost, whether it will be covered by insurance and when he expects it to be widely available. But, he said, the company is “committed to getting this to patients who need it.”