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Over the last few decades, there have been exciting advances in the field of neuromodulation, or the use of external stimulation to intentionally change and regulate the electrochemical environment of the brain.  Helius Medical Technologies (Helius or HMT) is studying the PoNS device to determine whether use of the device, in combination with physical and cognitive therapy, can improve certain neurological symptoms.  It is important to note that the PoNS is an investigational device still in development, and is not cleared or approved for commercial distribution in the United States or Canada.  Helius plans to study the device in the US for mild-to-moderate traumatic brain injury (mTBI) and is currently studying the device in Canada for multiple sclerosis (MS).  HMT intends to use the results from the planned pivotal, multi-center mTBI study to support an application to FDA for commercial distribution.  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 mTBI” – launched on August 11th, 2015. (ClinicalTrials.gov ID: NCT02429167)

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