Clinical Trials

Success Backed by Science

Over the last few decades, there have been exciting advances in the field of neuroplasticity, which is the ability of the brain to form and reorganize synaptic connections, especially in response to learning or experience, or following injury. Helius has studied the PoNS® to determine whether its use in combination with physical therapy can improve balance and gait deficit because of a mild to moderate traumatic brain injury (mmTBI) or multiple sclerosis (MS).

Helius’ goal is to conduct further studies with PoNS® in neurological diseases and disorders, such as stroke, multiple sclerosis and cerebral palsy.

Current and Future PoNS Therapy™ Studies

Therapeutic Experience Program (“TEP”)

The Therapeutic Experience Program (“TEP”) is a Helius-sponsored, open-label, observational, interventional, multicenter outcome research trial designed to assess adherence to on-label PoNS Therapy™ for improvement in gait deficits for patients with MS in a real-world clinical setting. The study will rate individuals’ adherence to PoNS Therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome. The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (phase 1) to the end of unsupervised therapy (phase 2) in relation to the individual’s adherence to PoNS Therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.

The study will be conducted at 10 to 12 centers of excellence across the US. Enrollment is expected to begin in the Fall of 2022 and continue through mid-2023. A total of 50 to 60 individuals with MS are expected to participate in the program.

NYU Langone Health. Principal Investigator: Leigh E. Charvet, PhD
Shepherd Center: Principal Investigator: Deborah Backus, PT, PhD, FACRM
Oregon Health and Science University. Principal Investigator: Vijayshree Yadav, MD, MCR, FANA, FAAN
The MGH Institute of Health Professions, Inc. Principal Investigator: Prudence Plummer, PhD

We’re just getting started. Continue to visit this page often as it is updated regularly to reflect the status of Helius- sponsored trials.