Actively Recruiting
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
Led by Massachusetts General Hospital · Updated on 2026-05-14
25
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
E
ElectroCore INC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18-85 years of age
- Ruptured aneurysmal subarachnoid hemorrhage confirmed by angiography and treated by neurosurgical clipping or endovascular occlusion
- Modified Glasgow Coma Scale score of 10 or higher and Hunt Hess grade 1 to 4 within 72 hours of aneurysm rupture
- Enrollment and treatment with nVNS must begin within 72 hours of aneurysm rupture
- Provide legally obtained informed consent from the participant or authorized representative; telephonic consent allowed
- Female participants of reproductive age must have a negative pregnancy test (urine or blood)
You will not qualify if you...
- Use of any implanted electrostimulation device such as pacemaker, defibrillator, or deep brain stimulator
- No plan to secure aneurysm by surgery or endovascular treatment
- Previous neck dissection or radiation
- History of carotid artery disease or carotid surgery/dissection
- History of heart rhythm disorders including secondary or tertiary heart blocks, ventricular tachycardia, or supraventricular tachycardia including atrial fibrillation
- Presence of screws, metals, or devices in the neck
- Current participation in another investigational drug or device trial that may affect data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Aman B Patel, MD
CONTACT
A
Austin R Birmingham, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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