Status:
COMPLETED
Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Netherlands Organisation for Scientific Research
ElectroCore INC
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04050501
Start Date
October 9 2019
End Date
May 5 2025
Last Update
May 14 2025
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands