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    Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke
    (Elsevier Science Inc, 2022) Arsava, Ethem Murat; Topcuoglu, Mehmet Akif; Ay, Ilknur; Ozdemir, Atilla Ozcan; Gungor, Ibrahim Levent; Isikay, Canan Togay; Nazliel, Bijen
    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. (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/).
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    Determinants of in-hospital muscle loss in acute ischemic stroke- Results of the Muscle Assessment in Stroke Study (MASS)
    (Churchill Livingstone, 2023) Gungor, Levent; Arsava, Ethem Murat; Guler, Ayse; Isikay, Canan Togay; Aykac, Ozlem; Caglayan, Hale Zeynep Batur; Kozak, Hasan Huseyin
    Background & aims: There is a change in the mass and composition of paretic and non-paretic skeletal muscles in the chronic phase of stroke. The multi-center, prospective, and observational Muscle Assessment in Stroke Study (MASS) was performed to evaluate the degree of muscle loss during the in-hospital acute stroke setting and determine factors contributing to this loss.Methods: Acute dysphagic ischemic stroke patients (n = 107) admitted to neuro-intensive care units were evaluated by computed tomography on days 1 and 14 after admission to determine the cross-sectional muscle area (CSMA) at the level of the mid-humerus, mid-thigh, and third lumbar vertebra. The percentage change in CSMA and variables associated with this change were evaluated by univariate and multivariate analyses.Results: There were significant reductions in CSMA in all the muscle groups analyzed; the most prom-inent change was observed in the arms (both: 14.2 +/- 10.7%; paretic: 17.7 +/- 11.6%; non-paretic: 10.1 +/- 12.5%), followed by the muscles in the legs (both: 12.4 +/- 8.7%; paretic: 12.9 +/- 9.9%; non-paretic: 12.0 +/- 9.3%) and L3-vertebra level (5.6 +/- 9.8%) (P < 0.001 for all). Higher calorie (r =-0.378, P < 0.001) or protein (r =-0.352, P < 0.001) intake was negatively associated with the decrease in CSMA of upper extremities. A substantial protein (>= 0.4 g/kg/d) or calorie (>= 5 kcal/kg/d) gap between targeted or actual intake was related to a larger decrease in CSMA in all the anatomic regions (P < 0.05 for all). Other significant predictors of muscle loss included history of diabetes mellitus, male sex, higher BMI, in-hospital infections, and the necessity for invasive mechanical ventilation.Conclusions: There is a considerable degree of loss in the global muscle mass in acute ischemic stroke patients over a two-week period. Along with several factors, falling significantly behind the daily protein or calorie targets was related to the decrease in the muscle area. Trial registration information: clinicaltrials.gov identifier NCT03825419.(c) 2023 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.