Helius Medical Technologies has initiated a Phase III clinical trial to investigate the safety and effectiveness of the portable neuromodulation stimulator (PoNS) 4.0 device to treat balance disorder in patients with mild-to-moderate traumatic brain injury (mTBI).
Conducted in collaboration with the US Army Medical Research and Materiel Command (USAMRMC), the trial aims to serve as the basis to seek Canadian and US marketing approvals of the device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.
During the trial, the team will study the safety and effectiveness of the PoNS for cranial nerve noninvasive neuromodulation (CN-NINM) training in subjects with a chronic balance deficit due to mTBI.
Featuring 120 subjects, the seven-month double-blind, randomised, sham-controlled study is being conducted at the Montreal Neurofeedback Center, the Oregon Health & Science University Center for Regenerative Medicine, and the Orlando Regional Medical Center.
Helius CEO Philippe Deschamps said: "Traumatic Brain Injury (TBI) remains a serious public health problem both for the military and civilian populations for which there have been almost no new developments in treatment since the introduction of physical therapy several decades ago.
"There is also a large population of TBI patients who develop chronic symptoms, for which traditional physical therapy has proven ineffective."
USAMRMC acquisition principal assistant Dr Kenneth Bertram said: "We are excited to begin the clinical trials for the PoNS device as a potential treatment for symptoms of TBI in our wounded warriors."
The Montreal Neurofeedback Center will be the first site to begin recruitment and screening of the subjects. The primary endpoint at five weeks is improvement in chronic balance deficit as analysed by the Sensory Organization Test.
The study seeks to demonstrate that CN-NINM, which combines the PoNS device with a unique physiotherapy regiment, may provide new rehabilitative opportunities for patients suffering from chronic symptoms.
The US Department of Defense has reported approximately 200,000 cases of TBI in soldiers between 2000 and June 2010.