Research

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 neural 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 stroke or a mild to moderate traumatic brain injury (mmTBI) or multiple sclerosis (MS).

Helius is conducting additional studies with PoNS^® in neurological diseases and disorders, such as stroke, multiple sclerosis, and eventually expanding to Parkinson’s Disease and other conditions involving mobility deficits.

Current and Future PoNS Therapy™ Studies

Multiple Sclerosis

PoNS Therapeutic Experience Program (“PoNSTEP”)

The PoNS Therapeutic Experience Program (“PoNSTEP”) 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) based on 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 is being conducted at 5 centers of excellence across the US. Enrollment is now closed. A total of 40-50 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
Neurology Center of New England, Principal Investigator: Dr. Salvatore Napoli MD

Visit www.clinicaltrials.gov to learn more.

Traumatic Brain Injury

A recent Pacific Blue Cross initiative to establish the cost effectiveness of PoNS Therapy, performed by HealthTech Connex and conducted at the Surrey Clinic in British Columbia, Canada, has shown that PoNS Therapy can help patients with Traumatic Brain Injury return to work by improving their gait and balance deficit. To view more details on the study outcomes visit pac.bluecross.ca.

Stroke

Helius has initiated an open-label study for its FDA approval program in stroke. The program was established based on real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, and aims to establish the benefits of using PoNS Therapy, on dynamic gait and balance, as well as risk of falling and fall rate, in chronic stroke survivors (6 months or more post stroke). Under the direction of Mark Bowden, PT, PhD, Brooks Rehabilitation and with the participation of Shepherd Center under Michael Yochelson, M.D., MBA, FAAN, FAAPMR, the study will enroll 30 participants by the end of the year. Participation of additional clinical sites is planned. For more study details, go to Study Details.

Brooks Rehabilitation is also a participant in Helius’ ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina, which seeks to evaluate PoNS Therapy on dynamic gait and balance in chronic stroke survivors. As part of this evaluation, risk of falling and fall rate will be assessed as well. Dr. Kautz plans to enroll 60 participants by the end of the year. For more details, go to Study details.

The Québec Ministry of Health and Social Services (“MSSS”) is acquiring 30 Portable Neuromodulation Stimulator (“PoNS^®”) devices as part of an initiative to assess the value of using PoNS to treat patients suffering symptoms due to stroke. Additionally, the University of Montreal will acquire ten PoNS devices to be used in a research study assessing stroke recovery. Please visit the Quebec Ministry of Health for more information.

Risk of Falling

The purpose of this Canadian based program is to collect information on the effect of 14-week on-label PoNS Therapy, on the risk of falling and fall rate, as a result of gait/balance improvement in people by stroke or mild to moderate traumatic brain injury (TBI) or multiple sclerosis (MS), treated in a real-world clinical setting. The program seeks to enroll 20 participants and is currently undergoing in Montreal at Neuro-Concept by Dr. Murielle Grangeon. (https://www.neuro-concept.ca). Participation of additional rehabilitation sites is planned.