MedTrace Logo

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

NCT06336720 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Chronic Stroke Survivors

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.

Sponsors & Collaborators

  • Helius Medical Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-04-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06336720 on ClinicalTrials.gov