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Ear device could boost language after stroke – small trial underway

NCT ID NCT06403475

Symptom relief Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether a non-invasive device that stimulates the vagus nerve through the ear can help people with chronic aphasia (trouble finding words) after a stroke. Thirty-six participants will use the device at home while doing computer-based speech therapy for six weeks. The main goal is to see if the approach is safe, tolerable, and feasible, with a secondary look at whether it improves word-finding.

What this could mean

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

Active substance
transcutaneous vagus nerve stimulation (tVNS) device
What this could lead to
If this works, it could point toward a new, home-based way to improve language recovery in people with long-term aphasia after stroke.
What could go wrong
This is a very early, small pilot study with only 36 participants. It is designed mainly to test safety and feasibility, not effectiveness. There are no published studies on tVNS for aphasia yet, so results are uncertain.

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 36 people

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

Started

Apr 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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

18 years and older

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: * Supratentorial stroke at least 6 months prior to recruitment * Aphasia (with word finding difficulties) * Ability to engage in the programme (support can be provided for cognitive or receptive difficulties) * Sufficient vision to engage in the computer-based SLT programme Exclusion Criteria: * Implanted devices (e.g. pacemaker) or implanted stimulation devices * Currently receiving a programme of Speech and Language Therapy (SLT) * Damage to the vagus nerve * Symptomatic bradycardia/ 2nd or 3rd heart block * Pregnancy * Unable to speak English * Severe deafness (despite using hear aids)

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Conditions

The condition(s) this trial relates to.

aphasia stroke disorder

As listed by the trial registrant

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

Aphasia Chronic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

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