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Helius Medical announces statistically significant find in DGI in PoNSTEP study
The Fly

Helius Medical announces statistically significant find in DGI in PoNSTEP study

Helius Medical (HSDT) Technologies announced positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis. PoNSTEP Results: There were statistically significant findings in DGI during Phase 1 and Phase 2 among the 38 subjects who completed the treatment protocol for a total mean improvement of 5.00 at week 14. In Phase 2, average therapy adherence 71% and gait improvement was linearly associated with adherence, while, in Phase 1 adherence, was 89.5% and, consequently, not associated with improvement. In addition to mean 2.5 points improvement in DGI achieved in Phase 1, Phase 2, participants with greater than or equal to85% adherence improved mean 3.7 points; those with less than85% adherence improved mean 2.0 points, and the difference was statistically significant. 28 of 41 participants who completed the 14-wk therapy were reassessed at 6-months and only 1 of 28 showed greater than or equal to 30% decline in DGI. Mean decline in DGI was -4.1 with the 95% CI’s lower bound showing statistically reliable evidence that the true mean decline was no more than -9.4%.

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