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Non-invasive Vagus Nerve Stimulation for Aneurysmal Subarachnoid Hemorrhage

This study is looking at a device called gammaCore, which uses non-invasive vagus nerve stimulation (nVNS), to treat aneurysmal subarachnoid hemorrhage (SAH). SAH is a type of bleeding in the brain caused by a ruptured aneurysm. The study wants to see if using gammaCore is safe, practical, and helpful for patients after their aneurysm has been repaired. You might be able to join if you are 18-85 years old, have had a ruptured SAH that was repaired, and meet certain health criteria within 72 hours of the bleeding. The study will measure how often severe device-related problems occur and will also look at whether the treatment can reduce further bleeding, seizures, and improve survival. This study is currently unclear on its recruitment status and plans to enroll 25 participants.

Study design
This is a single-site, single-arm, open-label pilot study. All 25 participants will receive the active gammaCore device.
What's involved
You would receive two 2-minute non-invasive stimulations with gammaCore three times daily. Treatment initiation must occur within 72 hours of presumed aneurysm rupture.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed for severe adverse device events within 30 minutes of the first treatment dose, measured for up to 10 days post-rupture.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05103566

Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage

Recruiting
NAAges 18–85InterventionalTreatment
Massachusetts General Hospital
~25 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:gammaCore

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
Measured over up to 10 days post-rupture

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Explore related trials

Subarachnoid Hemorrhage

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Aman B Patel, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Aman B Patel, MD
[email protected]
617-726-3303
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, 18-85 years of age
Ruptured aneurysmal SAH confirmed by angiography and repaired by neurosurgical clipping or endovascular occlusion (coiling)
Modified Glasgow Coma Scale (mGCS) score ≥ 10 and Hunt Hess 1-4 within 72 hours of presumed aneurysm rupture
Enrollment and initiation of nVNS treatment must occur within 72 hours of presumed aneurysm rupture
Provide a legally obtained informed consent form from the participant or the legally authorized representative (LAR); telephonic consent is acceptable
Female participants of reproductive age must have a negative pregnancy test result (urine or blood)

Exclusion

Use of any concomitant electrostimulation device, including a pacemaker, defibrillator, or deep brain stimulator
No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated
Previous neck dissection or radiation
History of carotid artery disease or carotid surgery/dissection
History of secondary or tertiary heart blocks, ventricular tachycardia, or supraventricular tachycardia (SVT; including atrial fibrillation)
Screws, metals, or devices in the neck
Currently participating in an investigational drug or device clinical trial with potential to confound data collection

What this trial measures

  • The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.up to 10 days post-rupture

    The rate of serious adverse events, such as bradycardia, hypotension, and decline in modified Glasgow Coma Scale grade. Events are determined through continuous monitoring of vital signs, including but not limited to: blood pressure, O2 saturation, heart rate, routine blood work, EKG, and alarm trigger frequency.