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NCT Number: NCT07131696

The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous vagal nerve stimulation

Device

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.

Other names: tVNS

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marshall Holland, MD

CONTACT

[email protected]

2059343411

Sponsors and collaborators

Lead sponsor

Marshall Holland

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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