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Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- gammaCore (device)
Sponsor: Massachusetts General Hospital · Participants: 25 · Started: Oct 4, 2022
Contact the study team
- Aman B Patel, MD · Phone: 617-726-3303
- Austin R Birmingham, BS · Phone: 617-643-5547
Official record on ClinicalTrials.gov — NCT05103566
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
- Subarachnoid Hemorrhage
- Aneurysms
- Bleeding
- Intracranial Hemorrhages
- Brain Aneurysm
- Vascular Diseases
- Brain Diseases
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.