Med Rhythms’ first product intends to serve chronic stroke patients with walking difficulties. Its intervention is designed to digitize an evidence-based intervention known as Rhythmic Auditory Stimulation to directly stimulate the neural circuitry that controls movement.
Challenge was to improve the speed and quality of walking; efficiently capture a large number of data points with CRF and quickly activate sites
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. 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.”
Solution: User-friendly EDC platform with randomization that can quickly be deployed at research sites.
As the company 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. Castor EDC’s user-friendly form builder, advanced user management and workflow streamlines data capture for all your clinical trials. It was able to confidently move forward with the study knowing Castor could handle the amount of data they were collecting.
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. 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.
Result: MedRhythms receives Breakthrough Device designation from U.S. Food and Drug Administration.
While the study is ongoing; on June 15, 2020, MedRhythms announced to have received Breakthrough Device designation from the 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!