Safety and feasibility trial of motor cortex stimulation via an external pulse generator in order to augment rehabilitation in individuals post stroke

Professor John Reynolds0 个研究点目标入组 24 人开始时间: 2019年5月8日最近更新: 2020年9月21日

适应症

试验速览

暂无简介。

•To be included in the study, participants must meet all of the following inclusion criteria:
•1.Capable of understanding and signing an informed consent form
•2.Have a cortical or subcortical stroke at least 4 months earlier, screened by prior CT/MRI and verified by study MRI
•3.Aged at least 18 years on the day of consent
•4.Confirmation of intact cortical tracts by the presence of a TMS-elicited MEP recorded from the paretic upper limb.
•5.Been assessed by Physiotherapy and deemed suitable (likely to be able to participate in 80% or more of the 11 weeks of three-days-a-week of physiotherapy sessions).

•To be included in the study, participants must meet none of the following exclusion criteria:
•1.History of epileptic seizures
•2.Participants with pacemakers/defibrillators
•3.Participants who have contraindications for MRI and TMS
•4.Female participants who are or intend to become pregnant
•5.Participants who, in the opinion of the investigators, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
•6.Participants who have pain, significant musculotendinous or bony restrictions of the affected upper limb, chronic disease (other than stroke) that will independently cause significant disability or weakness of the affected upper limb.
•7.Any participant for whom the investigators believe, for any reason, that participation would not be an acceptable risk.

发起方

Professor John Reynolds