Recruiting

tVNS

Sponsor:

Marshall Holland

Code:

NCT07131696

Conditions

Aneurysmal Subarachnoid Hemorrhage

Vasospasm, Cerebral

Transcutaneous Vagal Nerve Stimulation (tVNS)

Endovascular Treatment

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Vagal Nerve Stimulation

Study Details

Brief summary:

The significance of developing a safe and effective therapy for aneurysmal subarachnoid hemorrhage (aSAH) patients suffering cerebral vasospasm (CVS) cannot be overstated. Vasospasm - a clamping down of normal arteries in the days following rupture - remains incredibly challenging to treat.1,2 Current drugs and minimally invasive surgical therapies are helpful, yet woefully insufficient. Symptomatic cerebral vasospasm afflicts about 30% of aneurysmal subarachnoid hemorrhage patients and nearly half will go on to suffer a stroke, despite aggressive medical care.1-3 The autonomic nervous system is a balance between sympathetic (fight or flight) and parasympathetic (rest and digest) influence with sympathetic overactivity and inflammation shown to play an important role in the development and severity of cerebral vasospasm.4,5,17-20 Prior studies of autonomic nervous system neuromodulation highlight its promise as a promising potential avenue to improve morbidity and mortality from CVS in aSAH.6-15 Despite progress, continued high levels of CVS morbidity and mortality stress the urgent need for exploration of neuromodulation therapy.

In this proposal, the study team will modulate the autonomic nervous system function in aSAH patients using transcutaneous vagal nerve stimulation (tVNS). tVNS involves placement of a stimulation electrode on the external ear to non-invasively stimulate a branch of the vagal nerve and increase parasympathetic influence. This device has FDA approval for epilepsy and cluster headache.

The study hypothesis is that neuromodulation of the autonomic nervous system with tVNS (increasing parasympathetic influence) reduces sympathetic overactivity and inflammation in aSAH resulting in decreased morbidity of CVS.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Vasospasm, Cerebral

Transcutaneous Vagal Nerve Stimulation (tVNS)

Endovascular Treatment

Study ID

NCT07131696

Start date

Feb 6, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tVNS

Interventions

Transcutaneous Vagal Nerve Stimulation

Participants will receive up to 4 sessions per day of up to 20-minute stimulation, over the next 10 days of their inpatient hospital stay, following endovascular treatment. Stimulation will be provided by the tVNS device through a small electrode placed around the ear that will send low intensity, pulsed, electrical pulses the vagus nerve.

Primary outcome measure

  • Number of participants affected by cerebral inflammation during the course of the study as assessed by laboratory markers in blood and cerebral spinal fluid [ Time Frame: Pre-op, Day 1, 2, 7, 10, and discharge (assessed up to 21 days) ]
  • Rate of blood flowing through the brain as assessed by transcranial doppler imaging [ Time Frame: Pre-op, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and discharge (assessed up to 21 days) ]
  • Number of participants experiencing sudden health issues during the study as determined by the need for ventriculoperitoneal shunt placement prior to discharge, length of hospital stay, and disposition upon discharge. [ Time Frame: Pre-op, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and discharge (assessed up to 21 days) ]

Central Contacts and Locations

Central contacts

Marshall Holland, MD

2059343411mtholland@uabmc.edu

Locations

UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

More Information

Sponsor

Marshall Holland

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • CVS
  • aSAH
  • tVNS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marshall Holland on 2026-08-11.