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

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dc.contributor.authorArsava, Ethem Murat
dc.contributor.authorTopcuoglu, Mehmet Akif
dc.contributor.authorAy, Ilknur
dc.contributor.authorOzdemir, Atilla Ozcan
dc.contributor.authorGungor, Ibrahim Levent
dc.contributor.authorIsikay, Canan Togay
dc.contributor.authorNazliel, Bijen
dc.date.accessioned2024-02-23T14:02:22Z
dc.date.available2024-02-23T14:02:22Z
dc.date.issued2022
dc.departmentNEÜen_US
dc.description.abstractBackground: 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. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).en_US
dc.description.sponsorshipEric Liebler; ElectroCore LLCen_US
dc.description.sponsorshipWe are thankful to Eric Liebler from ElectroCore LLC for his support during the study. The study was monitored by an independent contract research organization (Monitor CRO, _Istanbul, Turkey). An independent data monitoring committee was responsible for assessing safety outcomes at the interim analysis stage.en_US
dc.identifier.doi10.1016/j.brs.2022.10.012
dc.identifier.endpage1474en_US
dc.identifier.issn1935-861X
dc.identifier.issn1876-4754
dc.identifier.issue6en_US
dc.identifier.pmid36356829en_US
dc.identifier.scopus2-s2.0-85141950507en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage1467en_US
dc.identifier.urihttps://doi.org/10.1016/j.brs.2022.10.012
dc.identifier.urihttps://hdl.handle.net/20.500.12452/11676
dc.identifier.volume15en_US
dc.identifier.wosWOS:000895634600008en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofBrain Stimulationen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAcute Strokeen_US
dc.subjectVagus Nerveen_US
dc.subjectStimulationen_US
dc.subjectSafetyen_US
dc.subjectRandomized Trialen_US
dc.titleAssessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute strokeen_US
dc.typeArticleen_US

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