Helius Medical said today it and the U.S. Army Medical Research and Material Command have launched a phase 3 clinical trial of Helius’ portable neuromodulation stimulator.
The PoNS unit is designed to treat balance disorder in patients with mild-to-moderate traumatic brain injury, the Newtown, Pa.-based company said.
“Together with our partners at the USAMRMC, we are very pleased to announce the launch of our pivotal phase 3 mTBI trial today. Traumatic brain injury 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,” Helius CEO Philippe Deschamps said in a press release.
The double-blind, randomized, sham-controlled 120-patient trial will study the safety profile and effectiveness of the PoNS device for cranial nerve noninvasive neuromodulation, Helius said. The primary endpoint at 5 weeks will be improvement in chronic balance deficit.
“We are excited to begin the clinical trials for the PoNS device as a potential treatment for symptoms of TBI in our wounded warriors. We are committed to the laboratory and clinical research needed to improve the treatment of brain injury,” USAMRMC principal assistant for acquisition Dr. Kenneth Bertram said in a prepared statement.
Last week, Helius announced its cost sharing contract with the U.S. Army Medical Research and Materiel Command to support a trial of its portable neuromodulation stimulator, with the deal slated to assist in trials of the neuromodulation device.