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

NCT06470009 | Active Not Recruiting

• 1 other identifier: HMI-SA-PoNS-STK002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary safety endpoints

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

  12 week

Study Arms (2)

Arm 1

SHAM COMPARATOR

administration of translingual neurostimulation.

Device: Portable Neuromodulation Stimulator (PoNS)

Arm 2

ACTIVE COMPARATOR

administration of translingual neurostimulation.

Device: Portable Neuromodulation Stimulator (PoNS)

Interventions

Portable Neuromodulation Stimulator (PoNS) DEVICE

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.

Also known as: PoNS Therapy

Arm 1

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 (3)

Synaptic Health

Calgary, Alberta, T2G 3A5, Canada

Location

Neuphysio

London, Ontario, N6J 2K4, Canada

Location

Neuro-Concept

Verdun, Quebec, H4H1M5, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The active Study Intervention device will deliver high-pulse stimulation and the sham Study Intervention device will deliver no-pulse stimulation although participants will be instructed to not assume being assigned an active or sham device based on whether they can feel the stimulation in the tongue or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: June 12, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-09

Locations

CA (3)