Could a nerve block or ear stimulation prevent brain damage after a hemorrhage?
NCT ID NCT07577739
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
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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
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UT Southwestern Medical Center - Clements University Hospital NSICU
Dallas, Texas, 75390, United States
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Other studies related to the condition(s) this trial covers.
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- Could a simple aspirin boost brain recovery after aneurysm rupture?