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Could a simple ear device protect the brain after injury?

NCT ID NCT07384845

Disease control Sponsor: Clinical Hospital Centre Zagreb 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device that gently stimulates a nerve in the ear can reduce brain damage and inflammation after a traumatic brain injury or bleeding stroke. Sixty adults will be randomly assigned to receive either real stimulation or a sham (fake) treatment. Researchers will measure brain injury markers and inflammation levels in blood and spinal fluid to see if the device helps.

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 non-invasive way to protect the brain and reduce inflammation after a traumatic brain injury or stroke.
What could go wrong
This is a small, early-stage trial with only 60 people, so results may not apply to everyone. The device may not provide any benefit over sham treatment.

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 60 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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.

IInclusion Criteria: Patients over 18 years of age with a diagnosis of traumatic brain injury or acute subarachnoid hemorrhage due to rupture of an intracranial aneurysm, confirmed by brain CT or MRI. Exclusion Criteria: Patients under 18 years of age; patients with autoimmune diseases or malignant diseases; pregnant women; and patients for whom informed consent to participate in the study is not obtained.

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage brain injury traumatic brain injury

As listed by the trial registrant

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

Acute brain injury Immunomodulation Neuromodulation Transcutaneous vagus nerve stimulation

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • UHCZagreb

    Zagreb, 10000, Croatia

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