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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)

Montreal Neurofeedback Center (Montreal, Quebec): Recruitment closed

Orlando Regional Medical Center (Orlando, Florida): Recruitment closed

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

For recruitment information please contact Dr. Sarah Theodoroff at sarah.theodoroff@va.gov /503-220-8262 ext. 51948
or Lisa Buckley at buckleyl@ohsu.edu / 503-418-0085

HealthTech Connex, Inc. (Surrey, British Columbia): Recruitment closed

Virginia Commonwealth University (Richmond, Virginia): Recruitment closed

MedStar National Rehabilitation Hospital (Washington, D.C.): Recruitment open

For recruitment information contact Rahsaan J. Holley, MS, OTR at rahsaan.holley@medstar.net / 202-877-1875

University of Wisconsin - Madison (Madison, Wisconsin): Recruitment open

For recruitment information contact Brittany Moreno at bmoreno@wisc.edu / 608-890-2537

Registrational Trial: chronic balance and gait deficit due to MS
Scheduled to start in 2017.

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

Study is in progress at the Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin-Madison.
For information, contact jlruhland@wisc.edu, or seehttp://go.wisc.edu/i24mx8 (ClinicalTrials.gov ID: NCT02158494).
Recruitment is closed.

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.
For information contact – Marcel Mazaltarim M.Sc. at mmazal@neuromtl.com or 1-866-331-3431.
Recruitment is closed.