D Khurana1, S Kaul, N M Bornstein. 1. Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. dherajk@yahoo.com
Abstract
INTRODUCTION: In rat stroke models, sphenopalatine ganglion stimulation up to 24 h after stroke onset augments cerebral blood flow, reduces infarct volume and improves neurological deficits. The ischaemic stroke system 500 has been designed to stimulate the sphenopalatine ganglion in humans. OBJECTIVES: (1) To determine the safety and tolerability of the ischaemic stroke system 500 in acute ischaemic stroke within 24 h of stroke onset. (2) To determine the effectiveness of ischaemic stroke system 500 in acute ischaemic stroke treatment. DESIGN/ METHODS: Implant for augmentation of cerebral blood flow trial-1 is a multi-national open-label study in patients of acute ischaemic stroke in the anterior circulation with National Institutes of Health Stroke Scales 7-20. The treatment initiation will be within 24 h of stroke onset. The ischaemic stroke system is implanted adjacent to the sphenopalatine ganglion via the greater palatine canal using local anaesthesia and a minimally invasive approach. The treatment protocol is constituted as 3-4 h of daily stimulation over 5-7 days. CONCLUSIONS: The implant for augmentation of cerebral blood flow trial-1 will determine the safety and tolerability of the ischaemic stroke system 500 in acute ischaemic stroke as reflected by the incidence of adverse events.
INTRODUCTION: In ratstroke models, sphenopalatine ganglion stimulation up to 24 h after stroke onset augments cerebral blood flow, reduces infarct volume and improves neurological deficits. The ischaemic stroke system 500 has been designed to stimulate the sphenopalatine ganglion in humans. OBJECTIVES: (1) To determine the safety and tolerability of the ischaemic stroke system 500 in acute ischaemic stroke within 24 h of stroke onset. (2) To determine the effectiveness of ischaemic stroke system 500 in acute ischaemic stroke treatment. DESIGN/ METHODS: Implant for augmentation of cerebral blood flow trial-1 is a multi-national open-label study in patients of acute ischaemic stroke in the anterior circulation with National Institutes of Health Stroke Scales 7-20. The treatment initiation will be within 24 h of stroke onset. The ischaemic stroke system is implanted adjacent to the sphenopalatine ganglion via the greater palatine canal using local anaesthesia and a minimally invasive approach. The treatment protocol is constituted as 3-4 h of daily stimulation over 5-7 days. CONCLUSIONS: The implant for augmentation of cerebral blood flow trial-1 will determine the safety and tolerability of the ischaemic stroke system 500 in acute ischaemic stroke as reflected by the incidence of adverse events.
Authors: Hans T H Tu; Bruce C V Campbell; Soren Christensen; Patricia M Desmond; Deidre A De Silva; Mark W Parsons; Leonid Churilov; Maarten G Lansberg; Michael Mlynash; Jean-Marc Olivot; Matus Straka; Roland Bammer; Gregory W Albers; Geoffrey A Donnan; Stephen M Davis Journal: Int J Stroke Date: 2013-03-12 Impact factor: 5.266