Helius Medical Technologies Inc announces its partnership with Dr. Steve Kautz on an investigator-initiated study, conducted at the Medical University of South Carolina (MUSC), to evaluate cranial-nerve non-invasive neuromodulation (CN-NINM) and dynamic balance in chronic stroke survivors.
As part of the study, some patients will receive CN-NINM, which will be delivered using PoNS therapy. The Portable Neuromodulation Stimulator (PoNS) is an innovative nonsurgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait.
“Falls are a major post-stroke complication and developing an optimal rehabilitation program to improve dynamic balance is critical for reducing stroke related morbidity and economic burdens. Our study aims to evaluate the effects of PoNS therapy on the recovery of gait and postural stability and, in teaming with Helius, we hope to provide a framework for an innovative rehabilitation protocol.”— Steve Kautz, PhD, Chair, Department of Health Sciences and Research, College of Health Professions, MUSC
“MUSC is at the forefront of research in rehabilitation for stroke and other disabling neurologic conditions, and we are delighted to support this pilot trial in stroke with our PoNS devices. Now that the FDA has granted Breakthrough Designation to PoNS for the treatment of dynamic gait and balance deficits in patients with stroke, this collaboration will provide important information to inform our clinical research and upcoming registrational program, allowing us to observe the functional outcomes of PoNS therapy in stroke patients in a real-world clinical setting. We look forward to working with Dr. Kautz and MUSC on this and future studies.”— Antonella Favit-Van Pelt, MD, PhD, Helius’ Chief Medical Officer
The study will be a placebo-controlled experimental design in which stroke survivors will participate in balance and gait training for 3 sessions per week, 40 minutes per session, for 4 weeks. MUSC anticipates enrolling 12 participants beginning in early 2022.
[Source(s): Helius Medical Technologies Inc, GlobeNewswire]