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 Phase III 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 open
Orlando Regional Medical Center (Orlando, Florida): Recruitment open
For recruitment information contact Linda Papa, MD or Ciara Tan, MSHS at firstname.lastname@example.org / 321-841-4129
or visit http://www.orlandohealth.com/clinical-trials/treatment-trial-for-1500801-nhctbiponsrt001-nct02429167
Oregon Health & Science University, Center for Regenerative Medicine/Portland VA Hospital (Portland, Oregon): Recruitment open
For recruitment information please contact Dr. Sarah Theodoroff at email@example.com /503-220-8262 ext. 51948
or Lisa Buckley at firstname.lastname@example.org / 503-418-0085
HealthTech Connex, Inc. (Surrey, British Columbia): Recruitment open
Virginia Commonwealth University (Richmond, Virginia): Recruitment open
For recruitment information contact Alison Molitor at email@example.com / 804-628-2902
MedStar National Rehabilitation Hospital (Washington, D.C.): Recruitment open
For recruitment information contact Rahsaan J. Holley, MS, OTR at firstname.lastname@example.org / 202-877-1875
Registrational Phase III 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 email@example.com, 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 firstname.lastname@example.org or 1-866-331-3431.
Recruitment is closed.