Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.

NCT06470009 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-08

No results posted yet for this study

Summary

Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.

Conditions

  • Chronic Stroke Survivors

Interventions

DEVICE

Portable Neuromodulation Stimulator (PoNS)

The PoNS device does not deliver stimulation produced by amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes plus physical therapy.

DEVICE

Portable Neuromodulation Stimulator (PoNS)

The PoNS device delivers stimulation produced by amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes plus physical therapy.

Sponsors & Collaborators

  • Helius Medical Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-07-30
Completion
2026-09-30

Countries

  • Canada

Study Locations

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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 NCT06470009 on ClinicalTrials.gov