MedRhythms, a digital therapeutics company based in the United States, uses sensors, music, and software to build evidence-based, neurologic interventions to measure and improve walking. Intended to be a rehabilitative device for walking improvement, MedRhythms’ first product intends to serve chronic stroke patients with walking difficulties, seeking to improve the speed and quality of walking. MedRhythms’ intervention is designed to digitize an evidence-based intervention known as Rhythmic Auditory Stimulation to directly stimulate the neural circuitry that controls movement. This neurological process is known as entrainment and can, over time, both enhance neuroplasticity as well as cause neuroplastic changes that produce improved motor outcomes.
Efficiently capture a large number of data points with CRF and quickly activate sites
User-friendly EDC platform with randomization that can quickly be deployed at research sites
MedRhythms receives Breakthrough Device designation from the US FDA
To support the proposed indications for use, MedRhythms needed to conduct a pivotal study. As a novel medical device, the pivotal study had to be designed as a randomized controlled trial where both efficacy and safety data would be collected in a healthcare setting to support market access in the United States. Physical therapists served as investigators who oversaw participant recruitment, enrollment, therapy sessions and closeout visits alongside research-dedicated staff.
With more than a dozen study visits per participant, the study captured a significant amount of data on gait characteristics, device performance and participant quality of life information. In order to meet quality regulations, MedRhythms also needed an electronic case report form (eCRF) system robust enough that it could be monitored in real time to quickly get a snapshot of study progress.
According to Clinical and Regulatory Affairs Manager, Danielle Briggeman, “utilizing an EDC became a requirement to ensure successful execution of the study given the number of data points we were collecting.”
Image: A patient participating in a MedRhythms music therapy session.
As MedRhythms neared finalizing their study protocol, they realized that a paper case report form (CRF) was going to be burdensome to develop, monitor and transcribe to electronic format for statistical analyses. They needed an electronic case report form system that could be monitored in real time to quickly get a snapshot of study progress. MedRhythms selected Castor as their EDC, citing Castor’s transparency with cost predictions, user-friendliness, and the ability to try a full version of Castor before buying.
Briggeman states, “We knew we wanted a high quality and compliant solution that our study teams and ourselves would find easy to navigate. It’s very frustrating to work with a poorly designed EDC system with a difficult user interface like I’ve run into in the past. Castor’s templates, form builder, and randomization module were extremely helpful features.” MedRhythms was able to confidently move forward with the study knowing Castor could handle the amount of data they were collecting. “This is not a small study datapoint-wise, and the ability to easily build CRF forms to maximize the data quality we needed was invaluable.”
For MedRhythms, even monitoring turned out to be an easy component as well, since sites quickly grasped Castor’s intuitive layout. With Castor, study teams found it easy to log in, add a participant, randomize with Castor’s built-in randomization tool, and move on.
While the study is ongoing, on June 15, 2020, MedRhythms announced they had received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for their digital therapeutic to treat chronic stroke walking deficits.
MedRhythms is developing an entire pipeline of neurological products, including interventions for Parkinson’s Disease, Multiple Sclerosis, and Fall Prevention. Castor is proud to power the data collection for this innovative company!