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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 as a result of a mild-to-moderate traumatic brain injury (mmTBI) or MS.

PoNS™ is an authorized medical device commercially available in Canada intended 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. The device is also intended for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy in Canada.

In the US, PoNS is authorized and indicated for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis 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.

PoNS™ is authorized in Australia (AUS TGA) as a non-implantable neurostimulator intended for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. It is not yet commercially available.

Helius’ goal is to conduct further studies with PoNS™ in neurological diseases and disorders, such as stroke, multiple sclerosis and cerebral palsy. Please continue to visit this page often as it is updated regularly to reflect the status of Helius sponsored trials.

Therapeutic Experience Program (“TEP”)

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 ten to twelve Centers of Excellence across the United States. Enrollment is expected to begin in the Fall of 2022 and continue through mid-2023. A total of fifty to sixty patients with MS are expected to take part in the program.

NYU Langone Health. Principal Investigator: Leigh E. Charvet, PhD

Shepherd Center: Principal Investigator: Deborah Backus, PT, Ph.D., FACRM

Investigator-Initiated Study: Pilot Trial on Stroke

Study to be conducted at the Medical University of South Carolina (“MUSC”), to evaluate the effect of cranial nerve translingual neuromodulation on dynamic gait and balance in chronic stroke survivors. As part of the study, some patients will receive translingual neurostimulation, delivered through PoNS Therapy.