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Could a tongue-stimulating device help stroke survivors regain their balance?

NCT ID NCT06336720

Symptom relief Sponsor: Helius Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called PoNS that stimulates the tongue to improve walking and balance in people who had a stroke at least 6 months ago. 30 participants will use the device along with physical therapy for 12 weeks. The main goal is to check safety, but researchers will also measure if it helps with balance, reduces falls, and improves quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women ≥ 18 and \< 85 years of age with a diagnosis ischemic or hemorrhagic stroke at \> 6 months since stroke onset event. 2. FMA-LE scores \< 34 at screening with residual paresis in the lower extremity. 3. Able to walk at least 10 feet with or without assistive device. 4. FGA score \< 23 at screening. 5. Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6 6. Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program. Exclusion Criteria: 1. Pre-existing neurological disorders or previous stroke affecting the other hemisphere. 2. Severe arthritis or orthopedic problems that limit passive range of motion. 3. Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue. 4. Diagnosis of dementia or mild cognitive impairment 5. Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®) 6. Neurostimulation therapy over the previous 6 months 7. Cancer treatment within the past year. 8. Nonremovable metal orthodontic devices. 9. Oral health problems. 10. Chronic infectious diseases. 11. Pregnancy. 12. Sensitivity to nickel, gold or copper.

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic stroke survivors

Contacts and locations

Locations

  • Brooks Rehabilitation

    Jacksonville, Florida, 32216, United States

  • MGH Institute of Health Professions

    Boston, Massachusetts, 02129, United States

  • Neurology Center of New England, P.C.

    Foxborough, Massachusetts, 02035, United States

  • Rehabologym Corp

    Tarrytown, New York, 10591, United States

  • Shepherd Center

    Atlanta, Georgia, 30309, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.