electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of Stroke
ROCKAWAY, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that full enrollment has been achieved
for the TR-VENUS study of non-invasive vagal nerve stimulation (nVNS) for the acute treatment of stroke. TR-VENUS is a double blind, randomized, sham-controlled, multi-center clinical trial,
conducted at nine major medical centers across Turkey, supported by the Turkish Neurological Society and partially funded through an unrestricted research grant from electroCore.
Stroke is the second highest cause of death and the third leading cause of disability globally . Ischemic stroke, caused by arterial occlusion, is the most common type of stroke. The effectiveness of current management strategies (e.g. rapid reperfusion with intravenous thrombolysis and endovascular thrombectomy) is dependent on time to treatment. Treating stroke quickly and safely is imperative for maximizing the therapeutic benefits of therapy. electroCore’s small and portable nVNS device, gammaCore Sapphire, offers the opportunity for administration rapidly after the onset of stroke. The scientific hypothesis supporting the TR-VENUS study is based, in part, on preclinical evidence from studies conducted in the lab of Ilknur Ay at Massachusetts General Hospital, Harvard Medical School suggesting that vagus nerve stimulation (VNS) results in a protective effect against ischemic brain injury1.
The TR-VENUS study recruited a total of 60 subjects with ischemic stroke and eight subjects with hemorrhagic stroke. The primary objective was to assess the safety of nVNS in the setting of acute stroke by examining decreases in arterial blood pressure, severe bradycardia, progression of neurological deficits and death. Feasibility was also assessed by determining the proportion of allocated stimulation doses that could be administered. Secondary efficacy outcomes evaluated neurologic deficits and infarct growth. Top-line data will be reported once available and full results will be published in a peer reviewed medical journal later this year.
The lead investigators of the study, Professors Ethem Murat Arsava and Mehmet Akif Topcuoglu of the Department of Neurology, Hacettepe University in Ankara, Turkey, commented, “We are very pleased to have successfully completed enrollment of this Phase 2 trial to assess the safety and feasibility of nVNS for the acute treatment of stroke. We are hopeful that nVNS might be a viable option to improve the treatment of acute stroke.”
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