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Background: Non-invasive vagus nerve stimulation (nVNS) using a hand-held stimulator placed on the neck is an FDA-approved treatment for primary headache disorders. The safety of nVNS is unknown in stroke patients. Objective: To assess the safety and feasibility of nVNS for the acute treatment of stroke. Methods: TR-VENUS (clinicaltrials.gov identifier NCT03733431) was a randomized, sham-controlled, open-label, multicenter trial conducted in patients with acute ischemic stroke (IS) or intracerebral hemorrhage (ICH). Patients were randomly assigned to standard-dose nVNS, high-dose nVNS, or sham stimulation. The primary endpoint was a composite safety outcome defined as bradycardia or reduction in mean arterial blood pressure during treatment or progression of neurological or death within 24 h of treatment. The feasibility endpoints were the proportion of eligible subjects receiving nVNS within 6 h of symptom onset and the proportion completing all pre-specified treatment doses. Efficacy assessments included infarct growth from baseline to 24 h after treatment. Results: Sixty-nine patients (61 IS, 8 ICH) completed the study. The composite safety outcome was achieved in 32.0% in sham and 47.7% in nVNS group (p = 0.203). Treatment was initiated in all but two randomized patients. All dosed subjects received 100% of prespecified stimulations. A non-significant reduction in infarct growth was observed in the high-dose nVNS group (184.2% in sham vs. 63.3% in high-dose nVNS; p = 0.109). Conclusions: The results of this study suggest that nVNS may be safe and feasible in the setting of acute stroke. These findings support further development of nVNS as a potential treatment for acute ischemic stroke.

Objective: It has been reported that the mortality due to ischemic stroke is higher and the prognosis is worse in women compared with men. The aim of this study was to determine the etiologic subtypes, risk factors, and prognosis of acute ischemic stroke (AIS) in females. Materials and Methods: We reviewed the medical records of 957 patients who were admitted with AIS between January 2011 and May 2017. The patients’ records were analyzed and the demographic data, risk factors, National Institutes of Health Stroke Scale (NIHSS) scores at admission, and modified Rankin Scale (mRS) in the follow-up were recorded. We determined etiologic stroke subtypes using the Automated Causative Classification System. Results: In the study, 432 (45.1%) female patients [mean age: 71.2±14.7 (range: 21-100) years] and 525 (54.9%) male patients [mean age: 67.2±12.9 (range: 25-103) years] were included. The women were older than the men (p