Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Sham TDCS; Device: Anodal TDCS; Device: Cathodal TDCS; Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02473549
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Many individuals are often left with problems moving their arm and hand, months to even years after a stroke. Recent progress in research suggests the application of non-invasive brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with rehabilitation exercises can further improve a person's ability to move after stroke. However, the problem is that this doesn't work for everyone, and researchers do not know why. One reason may be that TDCS is currently applied using a one-size-fits-all approach. Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in the same way. But, researchers know this is not the case. For example, each person will likely have different amounts of damage to brain regions that control movements. A better understanding of how the stroke uniquely affects a person's brain will help us to know which is the correct type of TDCS to apply for that person. Therefore, the objective of this research is to determine whether the amount of damage to brain regions that control movements can predict which type of TDCS will be more effective to help a person improve their ability to move. Participants will undergo 1 session of magnetic resonance imaging, and three sessions of TDCS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Study Start: 2017-09-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• unilateral first time stroke in middle cerebral artery territory
• greater 3 months post-stroke
• able to raise arm onto a table from a seated position

Exclusion Criteria

• severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions
• severe apraxia and neglect
• neurodegenerative or psychiatric disease
• contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brain Stimulation	Cathodal TDCS	Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).
Brain Stimulation	Sham TDCS	Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).
Brain Stimulation	Magnetic Resonance Imaging (MRI)	Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).
Brain Stimulation	Anodal TDCS	Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI).

Primary Outcome Measures

Name	Time	Method
Change in accuracy of reaching (root mean square error) after 1 session of TDCS	1 day
Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS	1 day
Change in movement time (seconds) for reaching after 1 session of TDCS	1 day

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada