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Gentle nerve stimulation device for bleeding in the brain from a burst aneurysm

Tests gammaCore nerve stimulation in 25 adults with aneurysmal subarachnoid hemorrhage.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
Status
Recruiting
People taking part
25 people, planned
Started
4 Oct 2022
Expected to end
Apr 2029
Type of study
Interventional
Treatments tested
  • gammaCore
Record updated
14 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bleeding around the brain from a burst aneurysm (aneurysmal subarachnoid hemorrhage). The aneurysm must already be repaired. They will use the gammaCore device, which stimulates a nerve in the neck through the skin.

Age
18 to 85 years
Sex
Male or female
Disease stage
Burst aneurysm confirmed by angiography (a scan of the blood vessels). Modified Glasgow Coma Scale score ≥ 10 and Hunt Hess grade 1-4 within 72 hours of the presumed rupture. Treatment must start within 72 hours of the rupture.
Earlier treatment
The aneurysm must have been repaired by surgical clipping or by coiling through the blood vessels.
Biomarker or test result
Women who can have children must have a negative pregnancy test (urine or blood).

Main reasons for not taking part

  • Use of another electrical stimulation device, such as a pacemaker, defibrillator or deep brain stimulator
  • Aneurysm not treated by surgery or through the blood vessels
  • Past neck dissection surgery or neck radiation, or screws, metal or devices in the neck
  • History of carotid artery disease, carotid surgery or carotid dissection
  • History of second- or third-degree heart block, ventricular tachycardia or SVT, including atrial fibrillation

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • Use of any concomitant electrostimulation device, including a pacemaker, defibrillator, or deep brain stimulator
  • Previous neck dissection or radiation
  • Currently participating in an investigational drug or device clinical trial with potential to confound data collection
  • 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)
  • No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated
  • Screws, metals, or devices in the neck

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Aman B Patel, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Treatment groupTreatment being tested

    The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve.

    Treatment: gammaCore

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
Plain-language title
Gentle nerve stimulation device for bleeding in the brain from a burst aneurysmGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05103566, who can take part
Record updated
14 May 2026