An interventional study of gammaCore in Subarachnoid Hemorrhage, Aneurysmal, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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). The hypothesis is that two 2-minute non-invasive stimulations of the cervical branch of the vagus nerve with nVNS, 3 times daily (TID), is a safe, practical, and potentially effective treatment after SAH in the neurocritical care setting. After diagnosis and surgical repair of the SAH, patients admitted to the Neuroscience Intensive Care Unit (NeuroICU) at Massachusetts General Hospital (MGH) will be screened for eligibility. Upon providing informed consent, eligible patients will be enrolled, begin the treatment protocol, and will be monitored. Data collection will be completed using automated systems, electronic reports, and manual collection before, during, and after nVNS.
The primary objective is to examine the safety, feasibility, and possible efficacy of nVNS as a treatment after aneurysmal subarachnoid hemorrhage (SAH).
Safety will be assessed by the incidence of severe adverse device events (SADEs) following nVNS.
Feasibility of the nVNS implementation will be evaluated by the ability to deliver >85% of doses per protocol, report of minimal interference with current standard of care treatments and procedures in in the NeuroICU, and beginning of treatment within 72 hours of presumed aneurysm rupture.
Efficacy of nVNS will be explored using the following assessments:
The study period starts within 72 hours of presumed aneurysm rupture and ends at 10 days or discharge, if sooner.
The PI and co-investigators will conduct safety monitoring of this small, single-site, low-risk pilot study on a continuous basis, ensuring adherence to the Mass General Brigham (MGB) Institutional Review Board (IRB) guidelines accordingly.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 25 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve.
Device: gammaCore
Participants will receive two 2-minute non-invasive stimulations to the cervical branch of the vagus nerve (nVNS) three times daily with gammaCore, an FDA cleared device for the acute treatment and prevention of migraine and cluster headache. Intervention will begin within 72 hours post-rupture and end at 10 days post-rupture or discharge, whichever occurs first. The dosing regimen is supported by preclinical models and clinical data.
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
The rate of serious adverse events, such as bradycardia, hypotension, and decline in modified Glasgow Coma Scale grade. Events are determined through continuous monitoring of vital signs, including but not limited to: blood pressure, O2 saturation, heart rate, routine blood work, EKG, and alarm trigger frequency.
Time frame: up to 10 days post-rupture
The feasibility of nVNS in SAH subjects in the critical care setting.
The ability to deliver \>85% of nVNS doses as scheduled, report of interference with NeuroICU standard of care, and nVNS initiation within 72 hours of enrollment.
Time frame: up to 10 days post-rupture
The frequency of alarm triggers peri-nVNS.
The monitoring of alarm trigger frequency due to significant clinical decline in blood pressure, O2 saturation, and EKG. The multiple alarm triggers will be aggregated to report one value, the frequency of total alarm triggers peri-nVNS.
Time frame: up to 10 days post-rupture
The measure of subject disability using a modified Rankin Score at baseline, intervention completion (10 days), and follow up (90 days).
The clinician will document a modified Rankin Score (mRS) at baseline, intervention completion at 10 days or discharge, and follow up at 90 days. A modified Rankin Score (mRS) is on a scale from 0-6 and is used to measure the level of disability after subarachnoid hemorrhage (SAH) or other neurological injury. The score increases as the level of disability and need for continuous care increases. A score of 0 indicates that a patient has no residual symptoms, while a score of 6 indicates that a patient has died.
Time frame: at 10 days and 90 days post-rupture
The rate of established predictors of delayed cerebral ischemia (DCI) and outcome.
The rate of DCI related events such as seizure, vasospasm, elevated intracranial pressure (ICP), heart rate variability, and blood pressure variability. These events are monitored by electroencephalogram (EEG), angiography, transcranial doppler (TCD) ultrasound, computerized tomography (CT), and medical record review.
Time frame: up to 10 days post-rupture
The occurrence of ischemic complications.
Delayed cerebral ischemia (DCI) and ischemic stroke will be detected by routine CT scans and/or angiography.
Time frame: up to 10 days post-rupture
The self-reported assessment for the quality of life of patients with neurological disorders at follow up (90 days).
The Quality of Life in Neurological Disorders (NeuroQOL Cognitive 6a) assessment is a self-reported 6-question survey to score the health-related quality of life of patients with neurological disorders. Questions are answered on a scale from 1 to 5. A score of 1 is considered a poor self-assessment, while a score of 5 is very good. The NeuroQOL Cognitive 6a assessment will be completed by each participant at follow up, 90 days post-rupture.
Time frame: at 90 days post-rupture
The self-reported assessment for physical, mental, and social health at follow up (90 days).
The Patient-Reported Outcomes Measurement Information System (PROMIS-10 Global) self-assessment is a 10-question survey that evaluates physical, mental, and social health of patients. Self-assessment scores range from 1 to 5 or 0 to 10. A score of 1 is considered a poor self-assessment, while a score of 5 is excellent. A score of 0 is considered no pain, while a score of 10 is the worst pain imaginable. The PROMIS-10 Global assessment will be completed by each participant at follow up, 90 days post-rupture.
Time frame: at 90 days post-rupture
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Dec 2028, 74 months after the start.
Of 57 non-industry interventional studies with no phase under Subarachnoid Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's planned 74 months is above that.
Counting every sponsor, half of 67 studies reached it within 32 months; a quarter within 20 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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