Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) 4.0 device has met primary and secondary effectiveness endpoints in its registrational trial of patients with traumatic brain injury (TBI).
The multi-center, double-blind, randomized and sham-controlled study assessed the safety and effectiveness of the PoNS device for cranial nerve noninvasive neuromodulation (CN-NINM) training in 122 subjects with a chronic balance deficit due to mild-to-moderate TBI.
The PoNS is an investigational, non-invasive and wearable medical device, which will deliver neurostimulation through the tongue.
Clinical research demonstrated that electrical stimulation of the tongue activates two major cranial nerves, including trigeminal nerve and facial nerve.
Aged between 18 and 65, the subjects in the trial received five weeks of treatment, including two weeks in clinic and three weeks at home. They received physical therapy and either a high-frequency PoNS device (active) or a low-frequency PoNS device (control).
The trial’s primary effectiveness endpoint showed a trend toward a higher responder rate in the high frequency PoNS therapy group with 75.4% than in the low frequency PoNS therapy group with 60.7%.
According to the company, the primary effectiveness endpoint was not reached because low frequency pulse treatment had a significant therapeutic effect, while the secondary effectiveness endpoints showed statistically and clinically significant increases in composite SOT scores.
The firm also noted that primary and secondary safety endpoints were successfully achieved as measured by a decrease in falls and headaches in both groups.
Helius chief medical officer Dr Jonathan Sackier said: “We are very pleased with the findings from our registrational trial that demonstrate that PoNS therapy, deployed independently across our seven study sites, produced statistically significant improvements in balance from baseline, on average over three times the clinically significant amount.”
Helius chief medical officer Dr Jonathan Sackier said: “We are very pleased with the findings from our registrational trial that demonstrate that PoNS therapy, deployed independently across our seven study sites, produced statistically significant improvements in balance from baseline, on average over three times the clinically significant amount.”
Image: Helius Medical is assessing the PoNS device in a registrational trial of patients with traumatic brain injury. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.