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โ† Trials
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Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage

RecruitingNAAges 18 Years - 85 YearsAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • gammaCore
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Where

1 site
Massachusetts General Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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