RecruitingNot ApplicableNCT05103566

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

Sponsor

Massachusetts General Hospital

Enrollment

25 participants

Start Date

Oct 4, 2022

Study Type

INTERVENTIONAL

Conditions

Subarachnoid Hemorrhage, Aneurysmal

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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 Criteria7

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

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Interventions

DEVICEgammaCore

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.