Helius Medical Technologies, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, and the United States Army Medical Research and Materiel Command (USAMRMC) announce that the last subject has been enrolled in the registrational clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) device for the rehabilitation of chronic balance deficits caused by mild-to-moderate Traumatic Brain Injury (mTBI). The trial is intended to serve as the basis for Helius to submit applications for marketing clearance in the U.S., Canada and Europe for the PoNS device.
The trial, “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 mild-to-moderate traumatic brain injury (mTBI),” was conducted at seven sites in the U.S. and Canada: Oregon Health and Science University in Portland OR, Montreal Neurofeedback Center in Montreal, QB, Orlando Regional Medical Center in Orlando, FL, HealthTech Connex Inc. in Surrey, BC, MedStar National Rehabilitation Hospital in Washington D.C., Virginia Commonwealth University in Richmond, VA and the University of Wisconsin in Madison, WI. A total of 120 subjects have been enrolled in the trial and the primary endpoint, at five-weeks, is improvement in chronic balance deficit as analyzed by the NeuroCom Balance Manager - Sensory Organization Test (SOT). The SOT test is a six-condition assessment that identifies abnormalities in a patient’s use of the three systems that contribute to balance: somatosensory, visual, and vestibular. In addition, the registrational clinical trial included a wide-range of secondary outcome measures for evaluation.
“We are happy to announce that the mTBI trial has been fully recruited, with the last subject enrolled at the University of Wisconsin – Madison site. We thank all of our sites for their dedication to achieving this milestone,” said Helius’ CEO, Philippe Deschamps. “There is still significant work ahead, but this is an important milestone for this research program, our organization and our partnerships as we prepare our applications for marketing clearance from the regulatory agencies.”
In February 2013, Helius and the USAMRMC entered a Collaborative Research and Development Agreement (CRADA) to support the development of the company’s PoNS device and to support research into indications relevant to injured service members. In July 2015, the USAMRMC committed to a sole-source contractual agreement to support the execution of the registrational mTBI trial. Additional research in indications such as tinnitus, post-traumatic stress, or sleep disturbances may be supported through the CRADA.
“Traumatic Brain Injury (TBI) today remains a serious public health problem both for the military and civilian populations for which there has been very limited development in regards to treatment options. The USAMRMC is pleased with the progress of the PoNS research program and our partnership with Helius. This milestone is a significant step in the development of this potential treatment option for our wounded warriors,” said Dr. Kenneth Bertram, Principal Assistant for Acquisition, USAMRMC.