Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Infarct volume
Study Overview
Brief Summary
The main objective of the study will be to investigate whether treatment with non-invasive vagus nerve stimulation (nVNS) on top of best medical practice in acute ischemic stroke patients results in less infarct growth in the penumbra and smaller infarct volumes compared with those of patients not treated with nVNS. The study will be a prospective randomized clinical trial with blinded outcome assessment (PROBE design). 150 patients will be randomized to nVNS with the gammaCore Sapphire™ device on top of best medical practice versus best medical practice alone (including intravenous thrombolysis and/or thrombectomy if indicated). If patients are randomized to nVNS, two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. Thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. The stimulation side in the neck will be the radiological side of the stroke. The primary endpoint will be the final infarct volume on MRI scan on day 5 of patients treated with nVNS compared with those of patients not treated with VNS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
PROBE design
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ischemic stroke
- •Perfusion deficit on the admission CTP scan; the penumbra must comprise at least 1/3 of the total ischemic area (ischemic core and penumbra)
- •The infarct has to comprise the anterior circulation
- •Treatment has to start <12 hours after stroke onset
- •Patients or their representatives need to give their informed consent
Exclusion Criteria
- •A life expectancy of less than three months
- •mRS >2 prior to admission
- •Contra-indication for contrast CT
- •Contra-indications for VNS:
- •An active implantable medical device such as a pacemaker, deep brain stimulator, or any implanted electronic device
- •Symptomatic stenosis or dissection of the carotid artery (in these patients the other side will be stimulated unless a significant stenosis on the other side is present as well)
- •Structural abnormality e.g. lymphadenopathy, previous surgery or abnormal anatomy (in these patients the other side will be stimulated)
- •Metal cervical spine hardware or metallic implant near the stimulation site
- •Cervical vagotomy (in these patients the other side will be stimulated)
- •Pregnancy
Outcomes
Primary Outcomes
Infarct volume
Time Frame: On day 5
Final infarct volume on MRI scan
Secondary Outcomes
- Occurrence of depression in the first 90 days(On day 90)
- Penumbra recovery(On day 3)
- Tolerability of nVNS(On day 5)
- Occurrence of seizures in the first 90 days(On day of admission, day 5 and day 90)
- Quality of life after 90 days(On day 90)
- Blood-brain barrier measurement(On day 3)
- Feasibility of nVNS(On day 5)
- Occurrence of headache in the first 90 days(On day of admission, day 5 and day 90)
- NIHSS (National Institutes of Health Stroke Scale) on day 5(On day 5)
- Cognitive status on day 90(On day 90)
- Clinical outcome (modified Rankin Scale, mRS) on day 90(On day 90)
Investigators
Marieke JH Wermer, MD
Professor Doctor
Leiden University Medical Center