Helius Medical Technologies Inc, a neurotech company focused on neurological wellness, announces the launch of its Therapeutic Experience Program with NYU Langone Health as its first Center of Excellence. The TEP study is designed to assess adherence to Portable Neuromodulation Stimulator (PoNS) therapy in patients with multiple sclerosis.
“We are excited to partner with one of the nation’s premier academic medical centers on this important program aiming to provide US clinicians with the opportunity to evaluate PoNS therapy for MS patients with gait deficit in a real-world environment.
“Through NYU Langone Health and future Centers of Excellence, the TEP study will enable key opinion leaders in the management of MS to build their knowledge of PoNS therapy and advise the broader medical community.”— Antonella Favit-Van Pelt, MD, PhD, Helius’ Chief Medical Officer
“For people with mild to moderate symptoms of MS, gait deficit can greatly affect function, independence, and quality of life. So far, non-pharmacological interventions have had limitations, but Helius’ clinical evidence has shown that PoNS can be an effective therapeutic option for our patients.
“We’re thrilled to move forward and participate in the program as, for clinicians, the TEP study will answer a crucial scientific question: what impact does patient’s adherence to PoNS therapy regimen have on a meaningful therapeutic outcome?”— Leigh E. Charvet, PhD, NYU Langone Health
About the Therapeutic Experience Program
The Therapeutic Experience Program is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis in a real-world clinical setting.
The study will rate subjects’ 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 subject’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 United States, with an estimated four PoNS devices per site. Enrollment is expected to begin late in the fourth quarter of 2021 and continue through mid-2022. A total of 50 to 60 patients with MS are expected to take part in the program.
[Source(s): Helius Medical Technologies Inc, GlobeNewswire]