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Home device aims to boost brain power after injury

NCT ID NCT07428980

Symptom relief Sponsor: Shirley Ryan AbilityLab 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a device that gently stimulates a nerve in the ear, used at home for one hour a day over two weeks, could help improve thinking and memory in people with mild to moderate traumatic brain injury. Seven adults took part to see if the treatment was practical and acceptable. The goal was to gather early data on whether this approach might support cognitive recovery.

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 it works, this could point toward a convenient home-based way to help people with TBI recover thinking skills.
What could go wrong
This was a very small feasibility study with only 7 people, so results may not apply widely. The device may not improve cognition more than standard care.

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

7 people

The number who actually took part.

Started

Jan 2026

Finished

Apr 2026

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 to 75 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: * Age 18-75 years. * Formally diagnosed with traumatic brain injury. * Ability to independently use a keyboard. * Able to understand and communicate in English (according to clinical judgment). * Able to independently provide consent to participate. Exclusion Criteria: * Acute medical issues requiring close physician or nursing monitoring. * Bioelectrical implants, cerebral shunts, including pacemakers. * Anyone with sore or diseased skin area in the ear * Pregnancy or persons who are lactating. * Cardiac arrhythmia. * Epilepsy or seizure disorders. * Significant gross or fine motor weakness. * Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments. * Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test attached to this submission). * Current major depression diagnosis.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TBI (traumatic brain injury)

Contacts and locations

Locations

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611, United States

More trials for these conditions

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