ACTRN12619000692134
Recruiting
未知
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 sites24 target enrollmentMay 8, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Professor John Reynolds
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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