Non-invasive vagus nerve stimulation for treating aneurysmal subarachnoid hemorrhage
STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
This study is testing if a non-invasive device that stimulates the vagus nerve can safely help patients with aneurysmal subarachnoid hemorrhage recover better after their aneurysm ruptures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05103566 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a confirmed ruptured aneurysmal SAH who can initiate treatment within 72 hours of rupture.
Not a fit: Patients with concomitant electrostimulation devices or those who have not had their aneurysm secured will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-invasive treatment option that improves outcomes for patients suffering from aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While the use of nVNS is a novel approach in this context, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.