International journal of stroke : official journal of the International Stroke Society · 2009
Implant for augmentation of cerebral blood flow trial 1: a pilot study evaluating the safety and effectiveness of the Ischaemic Stroke System for treatment of acute ischaemic stroke.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Khurana D, Kaul S, Bornstein N M, ImpACT-1 Study Group
Аннотация
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.
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.