RECRUITING

Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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) 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.

Official Title

STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage

Quick Facts

Study Start:2022-10-04
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05103566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, 18-85 years of age
  2. * Ruptured aneurysmal SAH confirmed by angiography and repaired by neurosurgical clipping or endovascular occlusion (coiling)
  3. * Modified Glasgow Coma Scale (mGCS) score ≥ 10 and Hunt Hess 1-4 within 72 hours of presumed aneurysm rupture
  4. * Enrollment and initiation of nVNS treatment must occur within 72 hours of presumed aneurysm rupture
  5. * Provide a legally obtained informed consent form from the participant or the legally authorized representative (LAR); telephonic consent is acceptable
  6. * Female participants of reproductive age must have a negative pregnancy test result (urine or blood)
  1. * Use of any concomitant electrostimulation device, including a pacemaker, defibrillator, or deep brain stimulator
  2. * No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated
  3. * Previous neck dissection or radiation
  4. * History of carotid artery disease or carotid surgery/dissection
  5. * History of secondary or tertiary heart blocks, ventricular tachycardia, or supraventricular tachycardia (SVT; including atrial fibrillation)
  6. * Screws, metals, or devices in the neck
  7. * Currently participating in an investigational drug or device clinical trial with potential to confound data collection

Contacts and Locations

Study Contact

Aman B Patel, MD
CONTACT
617-726-3303
abpatel@mgh.harvard.edu
Sarah J Snyder
CONTACT
617-643-5547
ssnyder8@mgh.harvard.edu

Principal Investigator

Aman B Patel, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Aman B Patel, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-04
Study Completion Date2025-04

Study Record Updates

Study Start Date2022-10-04
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Aneurysm
  • Hemorrhage
  • Intracranial Hemorrhages
  • Cerebrovascular Disorders
  • Intracranial Aneurysm
  • Vascular Diseases
  • Aneurysm, Brain
  • Brain Diseases
  • Central Nervous System Diseases
  • Aneurysm, Ruptured

Additional Relevant MeSH Terms

  • Subarachnoid Hemorrhage, Aneurysmal