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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method called non-invasive vagus nerve stimulation (nVNS) for patients who have suffered from a specific type of brain bleed known as aneurysmal subarachnoid hemorrhage (SAH). In this study, 25 patients will receive treatment with a device called gammaCore, which gently stimulates the vagus nerve without the need for surgery. The researchers want to see if this treatment can help reduce the chances of the aneurysm worsening, lower the risk of seizures, and improve overall survival rates.

To be eligible for this trial, participants must be between 18 and 85 years old and have been diagnosed with a ruptured aneurysm that has been treated by surgery or another procedure. They should also have a certain level of consciousness and must start the treatment within 72 hours of the bleed. It’s important to note that individuals with certain medical conditions or devices in their body may not be able to participate. If you or a loved one qualifies, you can expect to be treated with the nVNS device and monitored closely for any changes in your condition.

Gender

ALL

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