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Can a gentle ear zap calm the Brain's overactive 'Fight or Flight' response?

NCT ID NCT07131696

Disease control Sponsor: Marshall Holland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether a non-invasive device that stimulates the vagus nerve through the ear can reduce harmful spasms in brain arteries that often occur days after an aneurysm rupture. The study will enroll 10 adults who have had this type of bleeding in the brain and will receive up to four 20-minute sessions of ear stimulation daily during their hospital stay. Researchers will measure inflammation markers and blood flow in the brain to see if this approach helps calm the body's stress response and improve 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 vagal nerve stimulation (tVNS) delivered through an ear electrode
What this could lead to
If effective, tVNS could offer a non-invasive way to reduce dangerous brain artery spasms after aneurysm rupture, potentially lowering stroke risk and improving recovery.
What could go wrong
This is a very small early trial (10 people) without a comparison group, so results may not be conclusive. The device is FDA-approved for other conditions but not specifically for vasospasm, and its benefit here is unproven.

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 10 people

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

Started

Feb 2026

Expected to finish

Sep 2029

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 to 65 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: * Provision of signed and dated informed consent * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or Female * 18-65 years of age * Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage * Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage * For females of reproductive potential: negative pregnancy test at time of treatment. * Plan to undergo standard of care treatment and follow-up Exclusion Criteria: * Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5) * Does not provide consent * Posterior circulation aneurysmal subarachnoid hemorrhage * Initial aneurysm treatment after post bleed day 1

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage intracranial vasospasm subarachnoid hemorrhage

As listed by the trial registrant

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

Aneurysmal subarachnoid hemorrhage Endovascular treatment Transcutaneous vagal nerve stimulation (TVNS) Vasospasm, cerebral

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

  • UAB Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

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