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Tests treatment safety and results for Subarachnoid Hemorrhage, Aneurysmal
Official title Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
ClinicalTrials.gov ID: NCT05103566
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.