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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 10 days and 90 days post-rupture
Awards & highlights
STORM Trial 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.Check my eligibility
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.See study design
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.
STORM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was mostly awake and able to respond after a suspected brain bleed.
Select...
I had a ruptured brain aneurysm that was treated with surgery or coiling.
STORM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 10 days and 90 days post-rupture
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 10 days and 90 days post-rupture
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The presentation of severe adverse device events (SADEs) within 30 minutes of nVNS first treatment dose.
Secondary outcome measures
The feasibility of nVNS in SAH subjects in the critical care setting.
The frequency of alarm triggers peri-nVNS.
Interventional procedure
+4 moreSTORM 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
2,933 Previous Clinical Trials
13,198,466 Total Patients Enrolled
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,225 Total Patients Enrolled
Aman B Patel, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will start nVNS treatment within 3 days after my aneurysm is suspected to have burst.My aneurysm has not been treated surgically or through a catheter.I am of childbearing age and have a negative pregnancy test.I was mostly awake and able to respond after a suspected brain bleed.I have had carotid artery disease or surgery on my carotid artery.You have screws, metals, or devices in your neck.I have a history of serious heart rhythm problems.I have had surgery or radiation on my neck before.I had a ruptured brain aneurysm that was treated with surgery or coiling.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total participant count of this experiment?
"Affirmative. Data available on clinicaltrials.gov verifies that this investigation, initially posted and later modified in October of 2022, is currently seeking participants. 25 subjects are needed to be collected from a single medical centre."
Answered by AI
Am I eligible to join the experiment?
"The current medical trial requires that all prospective participants have experienced subarachnoid hemorrhage and aneurysmal, in addition to meeting the age criteria of 18-80 years old. The goal is to enroll 25 individuals into this study."
Answered by AI
Are there any potential participants being welcomed into this experiment?
"Clinicaltrials.gov confirms that this active trial, initially posted on October 4th 2022, is still looking for participants. The study was last edited two days later."
Answered by AI
Can individuals over 40 years of age participate in this clinical investigation?
"As stipulated in the requirements for participation, any individual that wishes to be enrolled must fall within 18 and 80 years of age."
Answered by AI
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