Recruiting

nVNS

Sponsor:

Massachusetts General Hospital

Code:

NCT05103566

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

gammaCore

Study Details

Brief summary:

This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Study ID

NCT05103566

Start date

Oct 4, 2022

Status verified date

May, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve.

Interventions

gammaCore

Participants will receive two 2-minute non-invasive stimulations to the cervical branch of the vagus nerve (nVNS) three times daily with gammaCore, an FDA cleared device for the acute treatment and prevention of migraine and cluster headache. Intervention will begin within 72 hours post-rupture and end at 10 days post-rupture or discharge, whichever occurs first. The dosing regimen is supported by preclinical models and clinical data.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Aman B Patel, MD

617-726-3303abpatel@mgh.harvard.edu

Austin R Birmingham, BS

617-643-5547abirmingham@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Aman B Patel, MD

617-726-3303abpatel@mgh.harvard.edu

Austin R Birmingham, BS

617-643-5547abirmingham@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Aneurysm
  • Hemorrhage
  • Intracranial Hemorrhages
  • Cerebrovascular Disorders
  • Intracranial Aneurysm
  • Vascular Diseases
  • Aneurysm, Brain
  • Brain Diseases
  • Central Nervous System Diseases
  • Aneurysm, Ruptured

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-14.