Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke


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Arsava E. M., Topçuoğlu M. A., Ay I., Özdemir A. Ö., Gungor I. L., Togay Işıkay C., ...More

Brain Stimulation, vol.15, no.6, pp.1467-1474, 2022 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 15 Issue: 6
  • Publication Date: 2022
  • Doi Number: 10.1016/j.brs.2022.10.012
  • Journal Name: Brain Stimulation
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, EMBASE, MEDLINE, Psycinfo, Directory of Open Access Journals
  • Page Numbers: pp.1467-1474
  • Keywords: Acute stroke, Randomized trial, Safety, Stimulation, Vagus nerve
  • Gazi University Affiliated: Yes

Abstract

© 2022 The AuthorsBackground: 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.