Clinical Trial

PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study

Active, Not Recruiting
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Record status
This record was last updated January 8, 2026 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors. Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization. Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-03-26; most recent amendment 2026-01-07.
Status change: Recruiting → Active, Not Recruiting 2025-03-25
Trial Details
NCT Number NCT06336720
Lead Sponsor Helius Medical Inc
Conditions Chronic Stroke Survivors
Enrollment 30 participants
Start Date 2024-05-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-08