NCT04050501Completed
Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 14 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 5 Aug 2019
- Start date
- 9 Oct 2019
- Primary completion date
- 16 Nov 2023
- Lead sponsor
- Leiden University Medical Center
- Diseases
- Stroke
- NCT number
- NCT04050501
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 9 Oct 2019 to the primary completion date, 16 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- mRS \>2 prior to admission
- 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
Other
- A life expectancy of less than three months
- Contra-indication for contrast CT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.