NCT05103566 Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
| NCT ID | NCT05103566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Subarachnoid Hemorrhage, Aneurysmal |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-10-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2022-10-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Aman B Patel, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05103566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Subarachnoid Hemorrhage, Aneurysmal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05103566 currently recruiting?
Yes, NCT05103566 is actively recruiting participants. Contact the research team at abpatel@mgh.harvard.edu for enrollment information.
Where is the NCT05103566 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05103566 clinical trial?
NCT05103566 is sponsored by Massachusetts General Hospital. The principal investigator is Aman B Patel, MD at Massachusetts General Hospital. The trial plans to enroll 25 participants.