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

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.

Assessment of maternal cerebral blood flow velocity by transcranial Doppler ultrasound before delivery and in the early postpartum period.

OBJECTIVE: This prospective observational study aimed to identify the effects of labor on cerebral hemodynamics by measuring the middle cerebral artery (MCA) blood flow velocity by transcranial Doppler ultrasound (TCD), and the related factors just before delivery and within the 24 h after delivery. METHODS: The study included 35 healthy pregnant women with a gestational age of >37 weeks who were in labor and a control group including healthy, age-matched, nonpregnant women (n = 24). Demographic characteristics and significant clinical information of pregnant women were recorded. The MCA blood flow velocity was assessed by TCD just before and within 24 h after delivery. The parameters assessed by TCD were mean cerebral blood flow velocity (MCBFV), peak systolic velocity (PSV), pulsatility index (PI), resistance index (RI), and systolic/diastolic ratio. RESULTS: There was no significant difference between the pregnant and nonpregnant women regarding age (27 ± 5 years versus 28 ± 7 years; p = .751). The MCBFV, PSV, PI, and RI showed a significant increase within the 24 h after delivery as compared with those before delivery. Comparison of the pregnant women with the control group in terms of the values of all parameters related to the MCA blood flow velocity revealed that the values that were significantly low before delivery reached to the level of the control group after delivery Conclusion: The findings of this study demonstrated that the blood flow velocity of the MCA decreased during the late pregnancy period and increased in the early postpartum period to the level similar to that of the nonpregnant group.