Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke
NOVIS
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
October 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2025
CompletedMay 14, 2025
May 1, 2025
4.1 years
August 5, 2019
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct volume
Final infarct volume on MRI scan
On day 5
Secondary Outcomes (11)
Feasibility of nVNS
On day 5
Tolerability of nVNS
On day 5
NIHSS (National Institutes of Health Stroke Scale) on day 5
On day 5
Clinical outcome (modified Rankin Scale, mRS) on day 90
On day 90
Occurrence of seizures in the first 90 days
On day of admission, day 5 and day 90
- +6 more secondary outcomes
Study Arms (2)
non-invasive Vagus Nerve Stimulation
ACTIVE COMPARATORnon-invasive Vagus Nerve Stimulation on top of best medical practice
Standard Care
NO INTERVENTIONBest medical practice alone
Interventions
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.
Eligibility Criteria
You may qualify if:
- Ischemic stroke
- NIHSS ≥1
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Netherlands Organisation for Scientific Researchcollaborator
- ElectroCore INCcollaborator
Study Sites (1)
Leiden University Medical Center
Leiden, Netherlands
Related Publications (1)
van der Meij A, van Walderveen MAA, Kruyt ND, van Zwet EW, Liebler EJ, Ferrari MD, Wermer MJH. NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial. Trials. 2020 Oct 26;21(1):878. doi: 10.1186/s13063-020-04794-1.
PMID: 33106174DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marieke JH Wermer, MD PhD
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- PROBE design
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 8, 2019
Study Start
October 9, 2019
Primary Completion
November 16, 2023
Study Completion
May 5, 2025
Last Updated
May 14, 2025
Record last verified: 2025-05