Non-invasive vagus nerve stimulation for treating aneurysmal subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS) using the gammaCore device for patients with aneurysmal subarachnoid hemorrhage (SAH). Conducted at Massachusetts General Hospital, the study will enroll 25 patients who will receive nVNS treatment within 72 hours of aneurysm rupture. The primary outcomes include monitoring the incidence of severe adverse events, treatment feasibility, and potential efficacy in reducing aneurysm rupture rates and improving survival. Data will be collected through automated systems and manual reports throughout the treatment process.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Aman B Patel, MD — Massachusetts General Hospital
• Study coordinator: Aman B Patel, MD
• Email: abpatel@mgh.harvard.edu
• Phone: 617-726-3303

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.