Shepherd Center and Helius Medical Technologies, Inc., Collaborate on Therapeutic Experience Program for People with Multiple Sclerosis
Research trial will evaluate therapy to improve balance and gait in people with MS.
Shepherd Center has joined Helius Medical Technologies, Inc.’s Therapeutic Experience Program (TEP). The Atlanta-based neurorehabilitation hospital joins NYU Langone Health and the MGH Institute of Health Professions as the third Center of Excellence in this Helius-sponsored open-label observational trial designed to evaluate the impact of participants’ adherence to Portable Neuromodulation Stimulator (PoNS) therapy in patients with multiple sclerosis (MS). Led at Shepherd Center by Deborah Backus, PT, Ph.D., FACRM, vice president of research and innovation and director of multiple sclerosis research at the Virginia C. Crawford Research Institute at Shepherd Center, the collaboration aims to bring additional therapies to people with MS.
“Our Therapeutic Experience Program enables clinicians to evaluate the effectiveness of PoNS therapy for people with MS who have gait deficit in a real-world environment while providing important information about PoNS therapy to key opinion leaders in MS management.”, said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' chief Medical officer. “The Virginia C. Crawford Research Institute at Shepherd Center is an important partner to the TEP, and we are thrilled with Dr. Backus’s contribution to our efforts of bringing innovative therapies to people with MS. Shepherd Center is one of the top 10 rehabilitation hospitals in the United States with a world-renowned Multiple Sclerosis Institute and integrated research program, and we look forward to a long-standing collaboration.”
“Shepherd Center is dedicated to improving the function, health, and quality of life in all people with MS. We are excited to partner with Helius on this important study,” said Dr. Backus. “People with MS often have decreased mobility, leading to more disability and less participation in daily life activities. We believe PoNS therapy can be an effective therapeutic option for our patients.”
About the Therapeutic Experience Program
The Therapeutic Experience Program (“TEP”) 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 (“MS”) 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 in the second quarter of 2022 and continue through late 2022. A total of 40 to 50 patients with MS are expected to take part in the program.
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy.
PoNS is also authorized for sale in Canada for two indications: (i) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.
Shepherd Center provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, traumatic amputations, stroke, multiple sclerosis, and pain. An elite center recognized as both Spinal Cord Injury and Traumatic Brain Injury Model Systems, Shepherd Center is ranked by U.S. News as one of the nation’s top hospitals for rehabilitation. Shepherd Center treats thousands of patients annually with unmatched expertise and unwavering compassion to help them begin again.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit heliusmedical.com.