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Could a nerve block or ear stimulation prevent brain damage after a hemorrhage?

NCT ID NCT07577739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at 300 adults with a brain bleed from a ruptured aneurysm. It tests a non-invasive headband to monitor brain blood flow and two nerve treatments (a neck injection and ear stimulation) to see if they improve brain function. The goal is to find better ways to prevent delayed brain injury and guide care in the ICU.

What this could mean

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

Active substance
Ropivacaine (local anesthetic) for cervical sympathetic block; transcutaneous auricular vagal nerve stimulation (taVNS) device
What this could lead to
If successful, this could lead to better, non-invasive ways to monitor brain health and prevent delayed complications after a brain bleed.
What could go wrong
This is an early-stage observational and feasibility study, not a treatment trial. The nerve stimulation and block are temporary and may not improve outcomes. Risks include side effects from the block (e.g., temporary Horner syndrome) and the stimulation.

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 300 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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 (Component 1 - All Enrolled Participants): * Age 18 years or older * Primary diagnosis of aneurysmal subarachnoid hemorrhage (aSAH), confirmed by imaging * Admitted to the NSICU at Clements University Hospital, UT Southwestern Medical Center * Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039) * Brain4Care extensometry sensor placeable at an appropriate cranial site not occluded by surgical dressings or EVD hardware * Open EVD with active continuous ICP monitoring (required for EVD clamping sub-protocol only; not required for Aims 2 or 3) Exclusion Criteria (Component 1): * Age younger than 18 years * Prisoner status * Primary NSICU admission diagnosis other than aSAH * Active declination by subject or legally authorized representative * Brain4Care sensor not placeable at any accessible cranial site * Active clinical deterioration making research monitoring impractical at time of approach * Physician-of-record declining research enrollment for clinical reasons * Inability to provide informed consent in English * Known pregnancy at time of enrollment Additional Inclusion Criteria for Component 2 (Aim 3 - CSB and taVNS): * At least one successful EVD clamping session completed * PI documentation of Component 2 operational readiness, co-signed by qualified co-investigator or Department Director * INR 1.5 or less and platelet count 50,000/uL or greater within 24 hours prior to each CSB procedure * No active infection or cellulitis at right anterolateral neck * No known allergy to ropivacaine or amide local anesthetics * No contralateral phrenic nerve palsy or severe pre-existing respiratory compromise * No cardiac pacemaker or implanted cardiac device contraindicating taVNS * No allergy to electrode adhesive materials * Continuous cardiac telemetry active and interpretable * Resting HR 60 bpm or greater on two readings within 24 hours prior to session * No current use of Class I or III antiarrhythmic medications * No clinically significant AV conduction abnormality Additional Exclusion Criteria for Component 2: * Prior ipsilateral right-sided cervical surgery, radiation, or known anatomical distortion precluding safe C6 approach * Hemodynamic instability with active vasopressor escalation at time of planned CSB * Active uncontrolled tachyarrhythmia or bradyarrhythmia at time of taVNS session * Physician-of-record declining autonomic modulation procedures for any clinical reason * Known or suspected pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • UT Southwestern Medical Center - Clements University Hospital NSICU

    Dallas, Texas, 75390, United States

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