tDCS and CO-OP in Chronic Stroke

Study Overview
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Brief Summary
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This project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tDCS) and metacognitive strategy training (MCST) in individuals with chronic stroke.

Detailed Description
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Currently seven million people are living in the United States post stroke, making stroke the leading cause of long term disability. Almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. This is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. The rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. Metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. Participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. Metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. Transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. While it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. Combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

Official Title
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Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

Conditions
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Chronic Stroke

Intervention / Treatment
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* Combination Product: tDCS and CO-OP Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 6 months post mild to moderate ischemic stroke self-reported functional limitations Age 30-80 Exclusion Criteria: history of other neurological diagnoses cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment) severe aphasia (greater than or equal to 2 on the NIHSS language item non-English speaking any additional condition where the PI deems participation unsafe pregnancy, 7) history of seizures medications that influence cortical excitability metallic implants above the chest history of welding or metalwork severe depressive symptoms (>21 on Patient Health Questionnaire)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: tDCS and CO-OP Group<br>One-hour session three times per week for 4 weeks. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. Following each tDCS session, the participants will complete a sensations questionnaire.The basis for each session will be task-based practice of client-chosen goals and the use of cognitive strategies using CO-OP. | Combination Product: tDCS and CO-OP Group<br>* Transcranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. CO-OP focuses on learning of a global problem-solving strategy, Goal-Plan-Do-Check (GPDC), within the performance of participant-chosen goals. Use of a broadly applicable strategy and meaningful activity ensures the intervention is salient to the participant and increases likelihood of transfer. Uniquely, therapists applying CO-OP use guided discovery methods to support participants in analyzing their own performance of a given task and generating potential solutions for improving performance. Participants become equipped with these skills through repetitive application of the Goal-Plan-Do-Check process.The intervention focuses on learning GPDC with gradual withdrawal of guided discovery methods.<br>* Other names: Brain Stimulation and Metacognitive Strategy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure | A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility | after study completion, an average of 5 weeks | 
| Semi-Structured Interview | A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention. | after study completion, an average of 5 weeks | 
| Client Satisfaction Questionnaire (CSQ-8) | Self-report, 8 item measures of intervention acceptability | after study completion, an average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Quality Rating Scale (PQRS) | An objective measure of participant performance of goals. Each goal is rated by a trained observer from 1 (no activity criteria were met) and 10 (all activity criteria were met). | Pre-intervention and post-intervention, typically an average of 5 weeks | 
| Canadian Occupational Performance Measure (COPM) | Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale | Pre-intervention and post-intervention, typically an average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Metacognitive Strategy Training, Brain Stimulation, CO-OP, tDCS