Akademik Veri Yönetim Sistemi
Diğer Uluslararası Fon Programları, 2019 - 2020
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 ¼ 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 ¼ 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.