MedTrace Logo

Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study

NCT03733431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-10-05

No results posted yet for this study

Summary

This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.

Conditions

  • Stroke, Acute
  • Stroke, Ischemic
  • Stroke
  • Stroke, Hemorrhagic

Interventions

DEVICE

Gammacore device

Transcutaneous stimulation of vagus nerve with the device positioned below the mandibular angle, medial to the sternocleidomastoid muscle and lateral to the larynx.

DEVICE

Gammacore sham device

Sham device which does not deliver electrical stimulation, but instead, produces a buzzing sound will be placed along the lateral border of the sternocleidomastoid muscle in order to avoid mechanical stimulation of the vagus nerve in the carotid triangle.

Sponsors & Collaborators

  • Turkish Neurological Society

    collaborator UNKNOWN

  • ElectroCore INC

    collaborator INDUSTRY

  • Turkish Stroke Research and Clinical Trials Network

    lead NETWORK

Principal Investigators

  • Ethem M Arsava, MD · Hacettepe University

  • Mehmet A Topcuoglu, MD · Hacettepe University

  • Hakan Ay, MD · Massachusetts General Hospital, Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2020-12-31
Completion
2021-04-01
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733431 on ClinicalTrials.gov