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PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Sponsor: Helius Medical Inc
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.
Official title: Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-05-01
Completion Date
2026-09-30
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
Portable Neuromodulation Stimulator (PoNS)
The active PoNS device delivers amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes.
Locations (5)
Brooks Rehabilitation
Jacksonville, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
MGH Institute of Health Professions
Boston, Massachusetts, United States
Neurology Center of New England, P.C.
Foxborough, Massachusetts, United States
Rehabologym Corp
Tarrytown, New York, United States