Helius Medical Technologies announced that its flagship PoNS technology would be tested in a double-blind, randomized, sham-controlled pilot efficacy study in volunteer human subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI).
The PoNS, an investigational medical device that induces neuromodulation by stimulating the cranial nerves found in the tongue, is being studied for the treatment of balance disorder symptoms caused by Traumatic Brain Injury (TBI).
The study is being conducted at the Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin-Madison. HMT is developing a commercial version of the prototype PoNS device used in the trial.
"There has been little advancement over the years for the treatment of symptoms caused by TBI and we are excited to help patients who have tried many different therapies and have limited treatment options," said Phillipe Deschamps, Chief Executive Officer, Helius Medical Technologies. "This pilot trial will guide next steps in the development of the PoNS™."
The 26-week pilot study is expected to include 44 subjects with a chronic balance deficit due to mild-to-moderate TBI. As part of the study, subjects will undergo periodic testing, in-lab exercise training with the PoNS for two weeks, and then will continue with PoNS use and exercise at home for 12 weeks. The last phase of the study is a 12-week withdrawal period.
Early clinical research shows that electrical stimulation of the tongue stimulates two major cranial nerves, the trigeminal and the facial. This stimulation is translated into neural impulses, delivered directly into the brain stem and dispersed throughout the brain. This stimulation of the brain stem and other brain structures seems to affect the capacity, organization, and function of these structures.
This is known as cranial nerve noninvasive neuromodulation (CN-NINM) and is delivered by the Portable Neuromodulation Stimulator (PoNS). When combining this neurostimulation with a specific set of physical, cognitive, and/or mental exercises, preliminary results have shown an increase in effectiveness in recovery and relief of targeted neurological symptoms.