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ACTIVE NOT RECRUITING
NCT06336720
NA

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

Sponsor: Helius Medical Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

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