30th April, 2020 – Helius Medical Technologies issued an announcement, which is summarized as follows:
Helius announced that its registrational clinical trial, TBI-001, was published on April 29, 2020 in Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatment? provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (“mmTBI”).
This newly-published, 122 subject, multicenter, double-blind randomized clinical trial, found that the PoNS Treatment, which pairs translingual neurostimulation using the Portable Neuromodulation Stimulator (PoNS?) device with therapeutic activities, significantly improves balance and gait. Conducted by researchers at 7 clinical sites across the US and Canada, this trial, which was completed in 2017, is the second double-blind, randomized clinical trial to demonstrate the level of balance improvement PoNS Treatment provides to patients suffering from chronic balance deficit as a result of a mild-to-moderate traumatic brain injury.
The TBI-001 trial evaluated subjects who had experienced a mild-to-moderate traumatic brain injury at least one year prior to receiving the PoNS Treatment and had reached a plateau in recovery (according to their healthcare providers) with physical therapy alone. Subjects used the PoNS device for 5 weeks in conjunction with therapeutic activities. At the end of the 5-week treatment program, patients demonstrated improved balance and gait. Researchers found that 67.2 percent of the pooled patient population who completed 5 weeks of PoNS Treatment experienced a clinically and statistically significant improvement in balance, as indicated in their mean SOT (Sensory Organizational Test) scores at 2 weeks and 5 weeks compared to baseline. Mean DGI (Dynamic Gait Index) scores were significantly increased from baseline at weeks 2 and 5.
Exploratory endpoints, such as the headache disability index, sleep quality index and quality of life measure index were also observed as part of the trial. While further analysis and research is needed, there was an indication of improvements in these exploratory endpoints. Demonstrated improvements in balance and gait, coupled with potential improvements in the exploratory endpoints, may allow treated individuals to experience improved quality of life.
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