Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment… (NCT05103566) | Clinical Trial Compass
RecruitingNot Applicable
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
United States25 participantsStarted 2022-10-04
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.