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Helius Medical Technologies Shares Positive Results from Clinical Trial
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.
Click here to read the full press release.
Source: globenewswire.com
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