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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™, an investigational medical device, to determine whether its use in combination with physical therapy, can improve balance deficit as a result of a mild-to-moderate traumatic brain injury (mmTBI).

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 currently under review for market authorization by the AUS TGA; PoNS™ is not commercially available in Australia or other markets.

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.

Registrational Trial: chronic balance deficit due to mild-to-moderate TBI

This multi-site study – “A double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS™ device for cranial nerve noninvasive neuromodulation (“CN-NINM”) training in subjects with a chronic balance deficit due to mmTBI” – launched on August 11th, 2015.

Recruitment is now closed at all study sites.

Montreal Neurofeedback Center (Montreal, Quebec)

Orlando Regional Medical Center (Orlando, Florida)

Oregon Health & Science University, Center for Regenerative Medicine/Portland VA Hospital (Portland, Oregon)

HealthTech Connex, Inc. (Surrey, British Columbia)

Virginia Commonwealth University (Richmond, Virginia)

MedStar National Rehabilitation Hospital (Washington, D.C.)

University of Wisconsin - Madison (Madison, Wisconsin)

Feasibility study: chronic balance deficit due to mild-to-moderate TBI

Study was completed at the University of Wisconsin-Madison.
For information see http://go.wisc.edu/i24mx8 (ClinicalTrials.gov ID: NCT02158494).

Feasibility study: chronic balance and gait deficit due to MS

Study was completed at McGill University’s Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center.
Published results - http://journals.sagepub.com/doi/pdf/10.1177/2055217317690561