External brain stimulation to augment rehabilitation therapy in individuals post stroke

Not Applicable

Recruiting

• Conditions: Stroke; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12619000692134
• Lead Sponsor: Professor John Reynolds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-08
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)[Baseline, 3 weeks, 7 weeks, 12 weeks of intervention phase; and 6 months post-intervention];Wolf Motor Function[Baseline,<br>3 weeks, 7 weeks, and 12 weeks of intervention phase, and <br>6months post-intervention];Upper Extremity Fugl-Meyer [Baseline,<br>3 weeks, 7 weeks, and 12 weeks of intervention phase, and <br>6months post-intervention]

Secondary Outcome Measures

Name	Time	Method
Functional MRI (exploratory)[Baseline, Immediately post-intervention and 6 months post-intervention];Resting EEG (exploratory)[Baseline, <br>3 weeks, 7 weeks, 12 weeks of intervention phase;<br>6 months post-intervention ];Adverse events (participant self-reported; e.g. headache).[Baseline, throughout the intervention phase, and 6 months post-intervention]