An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial

Publication date: Available online 24 May 2019Source: The LancetAuthor(s): Natan M Bornstein, Jeffrey L Saver, Hans Christoph Diener, Philip B Gorelick, Ashfaq Shuaib, Yoram Solberg, Lisa Thackeray, Milan Savic, Tamar Janelidze, Natia Zarqua, David Yarnitsky, Carlos A Molina, Ashfaq Shuaib, Michael Hill, Daniel Vaclavik, David Skoloudik, Jan Fiksa, Grethe Andersen, Pekka Jakala, Turgut TatlisumakSummaryBackgroundSphenopalatine ganglion stimulation increased cerebral collateral blood flow, stabilised the blood–brain barrier, and reduced infarct size, in preclinical models of acute ischaemic stroke, and showed potential benefit in a pilot randomised trial in humans. The pivotal ImpACT-24B trial aimed to determine whether sphenopalatine ganglion stimulation 8–24 h after acute ischaemic stroke improved functional outcome.MethodsImpACT-24B is a randomised, double-blind, sham-controlled, pivotal trial done at 73 centres in 18 countries. It included patients (men aged 40–80 years and women aged 40–85 years) with anterior-circulation acute ischaemic stroke, not undergoing reperfusion therapy. Enrolled patients were randomly assigned via web-based randomisation to receive active sphenopalatine ganglion stimulation (intervention group) or sham stimulation (sham-control group) 8–24 h after stroke onset. Patients, clinical care providers, and all outcome assessors were masked to treatment allocation. The primary efficacy endpoint was the difference between active and sham group...
Source: The Lancet - Category: General Medicine Source Type: research