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

NCT06336720 | Active Not Recruiting FDA Device

• 1 other identifier: HMI-SA-PoNS-STK001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary safety endpoints

  treatment - related serious adverse events (SAE) over 12 week treatment

  12 week

Study Arms (1)

Single Arm

OTHER

open label administration of translingual neurostimulation.

Device: Portable Neuromodulation Stimulator (PoNS)

Interventions

Portable Neuromodulation Stimulator (PoNS) DEVICE

The active PoNS device delivers amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes.

Single Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 and \< 85 years of age with a diagnosis ischemic or hemorrhagic stroke at \> 6 months since stroke onset event.
• FMA-LE scores \< 34 at screening with residual paresis in the lower extremity.
• Able to walk at least 10 feet with or without assistive device.
• FGA score \< 23 at screening.
• Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
• Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.

You may not qualify if:

• Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
• Severe arthritis or orthopedic problems that limit passive range of motion.
• Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
• Diagnosis of dementia or mild cognitive impairment
• Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
• Neurostimulation therapy over the previous 6 months
• Cancer treatment within the past year.
• Nonremovable metal orthodontic devices.
• Oral health problems.
• Chronic infectious diseases.
• Pregnancy.
• Sensitivity to nickel, gold or copper.

Sponsors & Collaborators

• Helius Medical Inc: lead

Study Sites (5)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

Location

Neurology Center of New England, P.C.

Foxborough, Massachusetts, 02035, United States

Location

Rehabologym Corp

Tarrytown, New York, 10591, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 29, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-09

Locations

US (5)