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

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. Objectiv...

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Bibliographic Details
Published in:International journal of stroke 2009-12, Vol.4 (6), p.480-485
Main Authors: Khurana, D., Kaul, S., Bornstein, N. M.
Format: Article
Language:English
Subjects:
Acute Disease
Adult
Aged
Brain Ischemia - complications
Brain Ischemia - therapy
Cerebrovascular Circulation - drug effects
Cerebrovascular Circulation - physiology
Cranial Nerves - physiology
Electric Stimulation Therapy - adverse effects
Electric Stimulation Therapy - methods
Electrodes, Implanted
Endpoint Determination
Female
Ganglia, Parasympathetic - physiology
Humans
ImpACT
ISS
Male
Middle Aged
Pilot Projects
Prospective Studies
protocol
Recovery of Function
stroke
Stroke - etiology
Stroke - therapy
treatment
Treatment Outcome
Vasodilation - physiology
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Summary: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.
ISSN:1747-4930
1747-4949
DOI:10.1111/j.1747-4949.2009.00385.x