Vagus Nerve Stimulation for Brain Aneurysm Bleeding
(STORM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Carotid disease, Heart blocks, SVT, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using any electrostimulation devices like a pacemaker, you cannot participate.
Is non-invasive vagus nerve stimulation (nVNS) safe for humans?
Non-invasive vagus nerve stimulation (nVNS), used in devices like gammaCore, has been shown to be safe and well-tolerated in humans, with a favorable safety profile and no significant device-related adverse events reported in studies for conditions like migraines.
12345How is the treatment gammaCore for brain aneurysm bleeding different from other treatments?
GammaCore is unique because it uses non-invasive vagus nerve stimulation (VNS) to potentially alter blood flow in the brain, which is different from traditional treatments that might involve surgery or medication. This approach is novel as it leverages a device to stimulate the vagus nerve externally, which has been used in other conditions like epilepsy and depression, but is now being explored for brain aneurysm bleeding.
678910Eligibility Criteria
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.Inclusion Criteria
I will start nVNS treatment within 3 days after my aneurysm is suspected to have burst.
I am of childbearing age and have a negative pregnancy test.
I was mostly awake and able to respond after a suspected brain bleed.
+3 more
Exclusion Criteria
My aneurysm has not been treated surgically or through a catheter.
I have had carotid artery disease or surgery on my carotid artery.
You have screws, metals, or devices in your neck.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Within 72 hours of aneurysm rupture
Treatment
Participants receive non-invasive vagus nerve stimulation (nVNS) using the gammaCore device, 3 times daily for up to 10 days or until discharge
Up to 10 days
Continuous monitoring in NeuroICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 10 days or discharge and 90 days post-rupture
90 days
Assessments at 10 days or discharge and 90 days post-rupture
Participant Groups
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.
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.
gammaCore is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as gammaCore for:
- Acute treatment of episodic cluster headache
- Acute treatment of migraine
- Preventive treatment of cluster headache
- Preventive treatment of migraine
- Abortive and preventive treatment of hemicrania continua and paroxysmal hemicrania
🇪🇺 Approved in European Union as gammaCore for:
- Cluster headache
🇬🇧 Approved in United Kingdom as gammaCore for:
- Cluster headache
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
ElectroCore INCIndustry Sponsor
References
Mechanism of action of non-invasive cervical vagus nerve stimulation for the treatment of primary headaches. [2018]Stimulation of the cervical vagus nerve with implanted vagus nerve stimulation (iVNS) has been used clinically for more than 20 years to treat patients with epilepsy. More recently, a non-invasive cervical vagus nerve stimulation (nVNS), gammaCore, was developed, which has been purported to also stimulate the vagus nerve without the cost and morbidity associated with an iVNS system. gammaCore has been used to acutely treat various types of primary headaches, including migraine and cluster headaches (CH), and for the prevention of episodic, chronic, and menstrual migraines and CH. The gammaCore device was cleared by the FDA for the acute treatment of pain in episodic CH patients. In this review, we summarize the clinical work that has been published in the use of gammaCore for treating primary headache disorders, present an overview of studies demonstrating that nVNS does indeed stimulate similar vagus nerve fibers as the implantable VNS system, and then present several animal headache-related studies that address the mechanism of action of nVNS.
Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. [2022]To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.
Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation. [2021]Noninvasive neurostimulation methods are particularly suited for migraine treatment thanks to their most favorable adverse event profile. Among them, noninvasive vagus nerve stimulation (nVNS) has raised great hope because of the role the vagus nerve is known to play in pain modulation, inflammation and brain excitability. We will critically review the clinical studies performed for migraine attack treatment and migraine prevention with the GammaCore® device, which allows cervical vagus nerve stimulation. nVNS is effective for the abortive treatment of migraine attacks, although the effect size is modest and numbers-to-treat appear not superior to those of other noninvasive neurostimulation methods, and inferior to those of oral triptans. The effect of nVNS with the GammaCore® in migraine prevention is not superior to sham stimulation, except possibly in patients with high adherence to the treatment. Both in acute and preventive trials, nVNS was characterized by an outstanding tolerance and safety profile, like the other noninvasive neurostimulation techniques. In physiological animal and human studies, cervical nVNS was shown to generate somatosensory evoked responses, to modulate pain perception and several areas of the cerebral pain network, and to inhibit experimental cortical spreading depression, which are relevant effects for migraine therapy.
Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. [2022]Recent clinical experiences and clinical trials have demonstrated the safety, tolerability, and efficacy of non-invasive vagus nerve stimulation (nVNS; gammaCore®) for the acute and prophylactic treatment of migraine. nVNS has a favorable adverse event profile, making it an attractive option for sensitive patient populations. We explored the safety, tolerability, and efficacy of nVNS as acute migraine treatment in adolescents. A group of adolescent patients suffering from migraine without aura were trained to use gammaCore to manage their migraine attacks. 46.8% of the treated migraine attacks (22/47) were considered successfully treated and did not require any rescue medication. No device-related adverse events were recorded. This preliminary study suggests that nVNS may represent a safe, well-tolerated, and effective for acute migraine treatment in adolescents.
Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial. [2023]The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication.
Brain blood-flow alterations induced by therapeutic vagus nerve stimulation in partial epilepsy: II. prolonged effects at high and low levels of stimulation. [2016]To measure vagus nerve stimulation (VNS)-induced cerebral blood flow (CBF) effects after prolonged VNS and to compare these effects with immediate VNS effects on CBF.
Quantitative estimation of nerve fiber engagement by vagus nerve stimulation using physiological markers. [2021]Cervical vagus nerve stimulation (VNS) is an emerging bioelectronic treatment for brain, metabolic, cardiovascular and immune disorders. Its desired and off-target effects are mediated by different nerve fiber populations and knowledge of their engagement could guide calibration and monitoring of VNS therapies.
Acute blood flow changes and efficacy of vagus nerve stimulation in partial epilepsy. [2019]To determine possible sites of therapeutic action of vagus nerve stimulation (VNS), by correlating acute VNS-induced regional cerebral blood flow (rCBF) alterations and chronic therapeutic responses.
A novel implantable vagus nerve stimulation system (ADNS-300) for combined stimulation and recording of the vagus nerve: pilot trial at Ghent University Hospital. [2012]Vagus nerve stimulation (VNS) is an established treatment for refractory epilepsy. The ADNS-300 is a new system for VNS that includes a rechargeable stimulus generator and an electrode for combined stimulation and recording. In this feasibility study, three patients were implanted with ADNS-300 for therapeutic VNS. In addition, compound action potentials (CAPs) were recorded to evaluate activation of the vagus nerve in response to VNS.
Vagus nerve stimulation: a proven therapy for treatment of epilepsy strives to improve efficacy and expand applications. [2020]Vagus nerve stimulation (VNS) is an approved therapy for the treatment of adult patients and adolescents aged 12 years and older who have partial onset seizures refractory to antiepileptic medications. More than 50,000 patients worldwide have been implanted with the VNS system. Work continues to understand the mechanism of action of VNS with the goal of improving the treatment, particularly to identify patients who will be helped by VNS, to develop a closed-loop seizure detection system, and to improve the selection of stimulation parameters. VNS has also been approved for treatment-resistant depression, and it may have utility in the treatment of a variety of other medical disorders.