Helius Medical Technologies announced new results from its trial on the safety and effectiveness of PoNS for the treatment of subjects with chronic balance deficits due to mild-to-moderate TBI.
Helius Medical Technologies (TSX:HSM; OTCQB:HSDT) announced new results from its trial on the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) for the treatment of subjects with chronic balance deficits due to mild-to-moderate TBI.
As quoted in the press release:
The multi-center registrational trial titled, A double-blind, randomized, sham-controlled study of the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) 4.0 device for cranial nerve noninvasive neuromodulation (CN-NINM) training in subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI), evaluated a total of 122 randomized subjects (61 active and 61 control). Subjects, age 18 to 65, received 5 weeks of treatment (2 weeks in-clinic and 3 weeks at-home) consisting of physical therapy and either a high-frequency PoNS device (active) or a low-frequency PoNS device (control).
Endpoints for effectiveness were assessed using the Sensory Organization Test (SOT), measuring balance using computerized dynamic posturography. A responder rate analysis was used for the primary endpoint. A responder was defined as a subject with an improvement of at least 15 points on the composite SOT score compared to baseline after 5 weeks of PoNS Therapy.