This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
69
Transcutaneous stimulation of vagus nerve with the device positioned below the mandibular angle, medial to the sternocleidomastoid muscle and lateral to the larynx.
Sham device which does not deliver electrical stimulation, but instead, produces a buzzing sound will be placed along the lateral border of the sternocleidomastoid muscle in order to avoid mechanical stimulation of the vagus nerve in the carotid triangle.
Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye)
Gazi University Faculty Of Medicine
Ankara, Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Ankara, Turkey (Türkiye)
Akdeniz University
Antalya, Turkey (Türkiye)
Eskişehir Osmangazi Faculty of Medicine
Eskişehir, Turkey (Türkiye)
Necmettin Erbakan University
Konya, Turkey (Türkiye)
Selcuk University
Konya, Turkey (Türkiye)
Ondokuz Mayıs University Faculty of Medicine
Samsun, Turkey (Türkiye)
Cardiovascular effects, clinical worsening or death (primary safety measure)
any of the following: * severe bradycardia (HR ≤50/min) during treatment application * significant decrease in arterial blood pressure (≥20 mmHg decrease in mean arterial blood pressure) during treatment application * neurological worsening (progression of neurologic deficit as shown by ≥ 4 points increase in NIH Stroke Scale Score) within 24 hours * death within 24 hours
Time frame: 24 hours
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