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.
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
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
Massachusetts General Hospital
Lead sponsor
ElectroCore INC
Collaborator