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Vagus Nerve Stimulator

Vagus Nerve Stimulation for Brain Aneurysm Bleeding (STORM Trial)

N/A
Recruiting
Led By Aman B Patel, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Modified Glasgow Coma Scale (mGCS) score ≥ 10 and Hunt Hess 1-4 within 72 hours of presumed aneurysm rupture
Ruptured aneurysmal SAH confirmed by angiography and repaired by neurosurgical clipping or endovascular occlusion (coiling)
Must not have
No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated
History of carotid artery disease or carotid surgery/dissection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 10 days and 90 days post-rupture
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a device that stimulates the vagus nerve can help people with aneurysmal subarachnoid hemorrhage. The device will be used on 25 people to see if it is safe and effective.

Who is the study for?
This trial is for adults aged 18-85 with a recent aneurysmal subarachnoid hemorrhage, who are conscious (mGCS score ≥ 10) and can start treatment within 72 hours of the rupture. It's not for those with neck surgeries, metal implants in the neck, heart rhythm problems, or using other electrostimulation devices.
What is being tested?
The study tests gammaCore, a non-invasive vagus nerve stimulator, on patients with brain aneurysm bleeding to see if it lowers rupture rates, seizures, bleeding severity and improves survival. All 25 participants will receive this active treatment.
What are the potential side effects?
Potential side effects of nVNS like gammaCore may include discomfort at the stimulation site or mild headaches. Since it's non-invasive and doesn't involve drugs or surgery, serious side effects are less likely compared to more invasive treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was mostly awake and able to respond after a suspected brain bleed.
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I had a ruptured brain aneurysm that was treated with surgery or coiling.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My aneurysm has not been treated surgically or through a catheter.
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I have had carotid artery disease or surgery on my carotid artery.
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I have a history of serious heart rhythm problems.
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I have had surgery or radiation on my neck before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 10 days and 90 days post-rupture
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10 days and 90 days post-rupture for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
Secondary study objectives
The feasibility of nVNS in SAH subjects in the critical care setting.
The frequency of alarm triggers peri-nVNS.
Interventional procedure
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
The gammaCore device supplies non-invasive stimulation to the cervical branch of the vagus nerve.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gammaCore
2020
N/A
~150

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,335 Total Patients Enrolled
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,181 Total Patients Enrolled
Aman B Patel, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

gammaCore (Vagus Nerve Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05103566 — N/A
Brain Aneurysm Research Study Groups: Treatment group
Brain Aneurysm Clinical Trial 2023: gammaCore Highlights & Side Effects. Trial Name: NCT05103566 — N/A
gammaCore (Vagus Nerve Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103566 — N/A
~0 spots leftby Dec 2024
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