brain ischemia Stroke
Conditions
Interventions
Patients will be randomized by computer to nVNS with the gammaCore Sapphire* on
top of best medical practice versus best medical practice alone (including
intravenous thrombolysis and/or thrombectom
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 supratentorial region - Treatment has to start
Exclusion criteria
Exclusion criteria: - Age below 18 - 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 or dissection 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the infarct volume on MRI scan after 5 days of patients treated with nVNS compared with those of patients not treated with VNS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be: o Feasibility and tolerability of nVNS o Proportion of patients in whom | — |
Countries
Netherlands
Outcome results
None listed