Subarachnoid Hemorrhage, AneurysmalSTORMNCT05103566
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
A study testing gammaCore in people with Subarachnoid Hemorrhage, Aneurysmal, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- gammaCore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Aman B Patel, MD, 617-726-3303, abpatel@mgh.harvard.edu
Austin R Birmingham, BS, 617-643-5547, abirmingham@mgh.harvard.edu
About this study
Official title: STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed description
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:
- subject disability measured using mRS at 10 days (or discharge) and 90 days after SAH
- effects on EEG, TCD, and ICP before, during, and after nVNS
- DCI/ischemic stroke detected by CT scans and/or angiography
- HR (heart rate), HR variability, and BP before, during, and after nVNS
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.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- gammaCore
- Keywords
- Aneurysm, Hemorrhage, Intracranial Hemorrhages, Cerebrovascular Disorders, Intracranial Aneurysm, Vascular Diseases, Aneurysm, Brain, Brain Diseases, Central Nervous System Diseases, Aneurysm, Ruptured
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm, Hemorrhage, Intracranial Hemorrhages, Cerebrovascular Disorders, Intracranial Aneurysm, Vascular Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaCoreDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve. Receives: Device: gammaCore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 days post-rupture
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 90 days post-rupture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start4 Oct 2022
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ElectroCore INC
- Responsible party
- Principal investigator, Aman B. Patel, M.D., Massachusetts General Hospital
- Investigators
- Aman B Patel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103566
- Sponsor's protocol ID
- 2021p002016
- Acronym
- STORM
- Status last verified
- May 2026
- First submitted
- 16 Sep 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Suzuki T, Takizawa T, Kamio Y, Qin T, Hashimoto T, Fujii Y, Murayama Y, Patel AB, Ayata C. Noninvasive Vagus Nerve Stimulation Prevents Ruptures and Improves Outcomes in a Model of Intracranial Aneurysm in Mice. Stroke. 2019 May;50(5):1216-1223. doi: 10.1161/STROKEAHA.118.023928.
PubMed 30943885Rosenthal ES, Biswal S, Zafar SF, O'Connor KL, Bechek S, Shenoy AV, Boyle EJ, Shafi MM, Gilmore EJ, Foreman BP, Gaspard N, Leslie-Mazwi TM, Rosand J, Hoch DB, Ayata C, Cash SS, Cole AJ, Patel AB, Westover MB. Continuous electroencephalography predicts delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study of diagnostic accuracy. Ann Neurol. 2018 May;83(5):958-969. doi: 10.1002/ana.25232. Epub 2018 May 16.
PubMed 29659050Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.
PubMed 23406828Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.
PubMed 22556195Lissak IA, Zafar SF, Westover MB, Schleicher RL, Kim JA, Leslie-Mazwi T, Stapleton CJ, Patel AB, Kimberly WT, Rosenthal ES. Soluble ST2 Is Associated With New Epileptiform Abnormalities Following Nontraumatic Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1128-1134. doi: 10.1161/STROKEAHA.119.028515. Epub 2020 Mar 11.
PubMed 32156203Lissak IA, Locascio JJ, Zafar SF, Schleicher RL, Patel AB, Leslie-Mazwi T, Stapleton CJ, Koch MJ, Kim JA, Anderson K, Rosand J, Westover MB, Kimberly WT, Rosenthal ES. Electroencephalography, Hospital Complications, and Longitudinal Outcomes After Subarachnoid Hemorrhage. Neurocrit Care. 2021 Oct;35(2):397-408. doi: 10.1007/s12028-020-01177-x. Epub 2021 Jan 22.
PubMed 33483913Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
PubMed 30217648Chen SP, Ay I, Lopes de Morais A, Qin T, Zheng Y, Sadeghian H, Oka F, Simon B, Eikermann-Haerter K, Ayata C. Vagus nerve stimulation inhibits cortical spreading depression. Pain. 2016 Apr;157(4):797-805. doi: 10.1097/j.pain.0000000000000437.
PubMed 26645547Ay I, Ay H. Ablation of the sphenopalatine ganglion does not attenuate the infarct reducing effect of vagus nerve stimulation. Auton Neurosci. 2013 Mar;174(1-2):31-5. doi: 10.1016/j.autneu.2012.12.001. Epub 2012 Dec 27.
PubMed 23273773Ay I, Lu J, Ay H, Gregory Sorensen A. Vagus nerve stimulation reduces infarct size in rat focal cerebral ischemia. Neurosci Lett. 2009 Aug 14;459(3):147-51. doi: 10.1016/j.neulet.2009.05.018. Epub 2009 May 13.
PubMed 19446004Ay I, Sorensen AG, Ay H. Vagus nerve stimulation reduces infarct size in rat focal cerebral ischemia: an unlikely role for cerebral blood flow. Brain Res. 2011 May 25;1392:110-5. doi: 10.1016/j.brainres.2011.03.060. Epub 2011 Mar 31.
PubMed 21458427Ay I, Nasser R, Simon B, Ay H. Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Ischemic Injury in Rats. Brain Stimul. 2016 Mar-Apr;9(2):166-73. doi: 10.1016/j.brs.2015.11.008. Epub 2015 Dec 1.
PubMed 26723020van der Meij A, van Walderveen MAA, Kruyt ND, van Zwet EW, Liebler EJ, Ferrari MD, Wermer MJH. NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial. Trials. 2020 Oct 26;21(1):878. doi: 10.1186/s13063-020-04794-1.
PubMed 33106174Pavlov VA, Wang H, Czura CJ, Friedman SG, Tracey KJ. The cholinergic anti-inflammatory pathway: a missing link in neuroimmunomodulation. Mol Med. 2003 May-Aug;9(5-8):125-34.
PubMed 14571320Dreier JP, Woitzik J, Fabricius M, Bhatia R, Major S, Drenckhahn C, Lehmann TN, Sarrafzadeh A, Willumsen L, Hartings JA, Sakowitz OW, Seemann JH, Thieme A, Lauritzen M, Strong AJ. Delayed ischaemic neurological deficits after subarachnoid haemorrhage are associated with clusters of spreading depolarizations. Brain. 2006 Dec;129(Pt 12):3224-37. doi: 10.1093/brain/awl297. Epub 2006 Oct 25.
PubMed 17067993
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT05103566
- Acronym / sponsor ID
- STORM / 2021p002016
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Aneurysm, Hemorrhage, Intracranial Hemorrhages, Cerebrovascular Disorders, Intracranial Aneurysm, Vascular Diseases, Aneurysm, Brain, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- ElectroCore INC
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- subject disability measured using mRS at 10 days (or discharge) and 90 days after SAH
- effects on EEG, TCD, and ICP before, during, and after nVNS
- DCI/ischemic stroke detected by CT scans and/or angiography
- HR (heart rate), HR variability, and BP before, during, and after nVNS
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: gammaCoreThe gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gammaCoreParticipants 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. | Device | Treatment group |
Primary outcome
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
Time frame: up to 10 days post-rupture
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.
7 secondary outcomes
The feasibility of nVNS in SAH subjects in the critical care setting.
Time frame: up to 10 days post-rupture
The frequency of 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).
Time frame: at 10 days and 90 days post-rupture
The rate of established predictors of delayed cerebral ischemia (DCI) and outcome.
Time frame: up to 10 days post-rupture
The occurrence of ischemic complications.
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).
Time frame: at 90 days post-rupture
The self-reported assessment for physical, mental, and social health at follow up (90 days).
Time frame: at 90 days post-rupture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 30943885Suzuki T, Takizawa T, Kamio Y, Qin T, Hashimoto T, Fujii Y, Murayama Y, Patel AB, Ayata C. Noninvasive Vagus Nerve Stimulation Prevents Ruptures and Improves Outcomes in a Model of Intracranial Aneurysm in Mice. Stroke. 2019 May;50(5):1216-1223. doi: 10.1161/STROKEAHA.118.023928.
- Background: PubMed 29659050Rosenthal ES, Biswal S, Zafar SF, O'Connor KL, Bechek S, Shenoy AV, Boyle EJ, Shafi MM, Gilmore EJ, Foreman BP, Gaspard N, Leslie-Mazwi TM, Rosand J, Hoch DB, Ayata C, Cash SS, Cole AJ, Patel AB, Westover MB. Continuous electroencephalography predicts delayed cerebral ischemia after subarachnoid hemorrhage: A prospective study of diagnostic accuracy. Ann Neurol. 2018 May;83(5):958-969. doi: 10.1002/ana.25232. Epub 2018 May 16.
- Background: PubMed 23406828Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.
- Background: PubMed 22556195Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.
- Background: PubMed 32156203Lissak IA, Zafar SF, Westover MB, Schleicher RL, Kim JA, Leslie-Mazwi T, Stapleton CJ, Patel AB, Kimberly WT, Rosenthal ES. Soluble ST2 Is Associated With New Epileptiform Abnormalities Following Nontraumatic Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1128-1134. doi: 10.1161/STROKEAHA.119.028515. Epub 2020 Mar 11.
- Background: PubMed 33483913Lissak IA, Locascio JJ, Zafar SF, Schleicher RL, Patel AB, Leslie-Mazwi T, Stapleton CJ, Koch MJ, Kim JA, Anderson K, Rosand J, Westover MB, Kimberly WT, Rosenthal ES. Electroencephalography, Hospital Complications, and Longitudinal Outcomes After Subarachnoid Hemorrhage. Neurocrit Care. 2021 Oct;35(2):397-408. doi: 10.1007/s12028-020-01177-x. Epub 2021 Jan 22.
- Background: PubMed 30217648Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
- Background: PubMed 26645547Chen SP, Ay I, Lopes de Morais A, Qin T, Zheng Y, Sadeghian H, Oka F, Simon B, Eikermann-Haerter K, Ayata C. Vagus nerve stimulation inhibits cortical spreading depression. Pain. 2016 Apr;157(4):797-805. doi: 10.1097/j.pain.0000000000000437.
- Background: PubMed 23273773Ay I, Ay H. Ablation of the sphenopalatine ganglion does not attenuate the infarct reducing effect of vagus nerve stimulation. Auton Neurosci. 2013 Mar;174(1-2):31-5. doi: 10.1016/j.autneu.2012.12.001. Epub 2012 Dec 27.
- Background: PubMed 19446004Ay I, Lu J, Ay H, Gregory Sorensen A. Vagus nerve stimulation reduces infarct size in rat focal cerebral ischemia. Neurosci Lett. 2009 Aug 14;459(3):147-51. doi: 10.1016/j.neulet.2009.05.018. Epub 2009 May 13.
- Background: PubMed 21458427Ay I, Sorensen AG, Ay H. Vagus nerve stimulation reduces infarct size in rat focal cerebral ischemia: an unlikely role for cerebral blood flow. Brain Res. 2011 May 25;1392:110-5. doi: 10.1016/j.brainres.2011.03.060. Epub 2011 Mar 31.
- Background: PubMed 26723020Ay I, Nasser R, Simon B, Ay H. Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Ischemic Injury in Rats. Brain Stimul. 2016 Mar-Apr;9(2):166-73. doi: 10.1016/j.brs.2015.11.008. Epub 2015 Dec 1.
- Individual participant dataSharing planned: No
Related trials for Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aman B Patel, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore in people with Subarachnoid Hemorrhage, Aneurysmal, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aman B Patel, MD (617-726-3303, abpatel@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose. (time frame: up to 10 days post-rupture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103566, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.