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

• DOI: 10.1016/j.brs.2022.10.012
• Publication Date: 2022-11-07T17:40:49Z
• Authors: Ethem Murat Arsava; Mehmet Akif Topcu...; Ilknur Ay; Atilla Ozcan Ozdemir; Ibrahim Levent Gu...; Canan Togay Isikay; Bijen Nazliel; Hasan Huseyin Kozak; Serefnur Ozturk; İbrahim Arda Yilmaz; Babur Dora; Hakan Ay; Ali Unal; Tugba Ozel; Mine Hayriye Sorgun; Eda Aslanbaba Bah...; Elif Peker; Ozlem Aykac; Zaur Mehdiyev; Hale Zeynep Batur...; Asli Akyol Gurses; Mehmet Yasir Pekt...; Ezgi Yilmaz; Dogan Dinc Oge; Safak Parlak; Ahmet Bugrul; Hilal Ozguner; Aysu Cetiner Seker; Gokhan Ozdemir; Gozde Ongun; Sueda Ecem Yilmaz; Cihat Ozguncu; Saziye Melike Tur...; Omer Faruk Ildiz; Azer Mammadli; Aydin Talip Yildogan; Candace McClure
• Keywords: Vagus Nerve Stimulation; Stroke; Clinical endpoint

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