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Can a tongue device help stroke survivors regain their balance?

NCT ID NCT05135533

Disease control Sponsor: Medical University of South Carolina 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether a device that gently stimulates the tongue, called PoNS, can improve balance and walking in people who had a stroke at least six months ago. Participants receive either real stimulation or a sham (inactive) device, along with balance training, over several weeks. The study measures changes in walking speed and dynamic balance to see if this approach helps with post-stroke recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Portable Neuromodulation Stimulator (PoNS) — a device that delivers mild electrical stimulation to the tongue, paired with gait and balance training.
What this could lead to
If effective, this approach could offer a non-invasive way to improve walking and balance in people recovering from stroke, potentially reducing fall risk and enhancing mobility.
What could go wrong
This is an early-stage trial with a modest number of participants, and results may not generalize. The stimulation is experimental, and benefits may be modest or not lasting beyond the treatment period.

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

53 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

22 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: * At least six months since the onset of Ischemic or hemorrhagic stroke. * Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34). * Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study. * Can walk at least 10 feet with and without assistive device. * Functional Gait Assessment score \<22. Exclusion Criteria: * Pre-existing neurological disorders. * Previous stroke affecting the other hemisphere . * Severe arthritis or orthopedic problems that limit passive range of motion. * Areas of recent bleeding or open wounds. * Lack normal sensation on the tongue. * Received treatment for cancer within the past year. * Non-removable metal orthodontic devices. * Oral health problems. * Are sensitive to nickel, gold or copper. * Chronic infectious diseases. * Are pregnant. * Have dementia

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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.

Stroke

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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