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Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke
- Source :
- Brain Stimulation, Vol 15, Iss 6, Pp 1467-1474 (2022)
- Publication Year :
- 2022
- Publisher :
- Elsevier, 2022.
-
Abstract
- 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.
Details
- Language :
- English
- ISSN :
- 1935861X
- Volume :
- 15
- Issue :
- 6
- Database :
- Directory of Open Access Journals
- Journal :
- Brain Stimulation
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.750f1b44b2574437bd68c356e0c39ca5
- Document Type :
- article
- Full Text :
- https://doi.org/10.1016/j.brs.2022.10.012