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

Study Overview
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Brief Summary
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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.

Official Title
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Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Sham TDCS
* Device: Anodal TDCS
* Device: Cathodal TDCS
* Device: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Stimulation<br>Patients will receive, Sham TDCS, Anodal TDCS, Cathodal TDCS, and Magnetic Resonance Imaging (MRI). | Device: Sham TDCS<br>* Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity<br>Device: Anodal TDCS<br>* Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity<br>Device: Cathodal TDCS<br>* Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity<br>Device: Magnetic Resonance Imaging (MRI)<br>* Participants will receive a MRI of their brain to allow the research investigators to determine how the stroke has affected regions of the brain processing movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in movement time (seconds) for reaching after 1 session of TDCS |  | 1 day | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor, rehabilitation, transcranial direct current stimulation