tDCS and Metacognitive Strategy Training in Stroke

Study Overview
=================
Brief Summary
-----------------
Specific Aim 1: Complete pilot testing of study protocol in individuals with chronic stroke for feasibility evaluation and protocol refinement. Specific Aim 2: Estimate the preliminary effect of CO-OP+tDCS on activity performance in individuals with chronic stroke.

Detailed Description
-----------------
A number of daily life activities are discontinued after stroke. These discontinued activities typically include basic self-care, instrumental activities of daily living, leisure, and work. These changes in participation contribute to decreased quality of life and life satisfaction. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a behavioral problem-solving intervention that focuses on teaching clients how to apply cognitive strategies to enhance learning and overcome activity performance barriers. CO-OP uses meaningful, client-chosen activities to drive new skill learning and neural reorganization. Consistent with these principles of neuroplasticity, transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method of modulating cortical excitability through application of low currents to targeted regions on the scalp. There are known positive effects of CO-OP to improve activity performance and for tDCS to improve impairment level outcomes post-stroke. The investigators hypothesize that the known effects of CO-OP may be amplified with use of tDCS to alter known neural hubs of executive networks that support problem-solving. In sum, (1) CO-OP is effective at improving activity performance, and (2) the effects of CO-OP may be amplified through novel methods that allow for placing the brain in an enhanced neuroplastic state, such as tDCS.

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

Conditions
-----------------
Chronic Stroke

Intervention / Treatment
-----------------
* Behavioral: CO-OP Procedures
* Device: tDCS
* Behavioral: Computer Cognitive Training Procedures
* Device: sham tDCS group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >6 months post-ischemic stroke not currently receiving therapy services a minimum of four self-identified functional goals Exclusion Criteria: severe depressive symptoms (>20 on Patient Health Questionnaire) dementia symptoms (<24 on Montreal Cognitive Assessment) any additional neurological disorders moderate-severe aphasia (NIH Stroke Scale aphasia scale of greater than or equal to 2) any tDCS contraindication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO-OP and tDCS group<br>Each session will consist of 20 minutes of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. This will be followed by 45 minutes of the assigned CO-OP. | Behavioral: CO-OP Procedures<br>* 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>Device: tDCS<br>* Each session will begin with 20 minutes of anodal tDCS applied to the ipsilesional dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. The cathode will be placed over the contralesional supraorbital area. Direct current will be applied through two saline soaked sponges placed on the scalp. The tDCS device contains software for double-blinded delivery.<br>|
| Active Comparator: CO-OP and sham tDCS group<br>Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP. | Behavioral: CO-OP Procedures<br>* 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>Device: sham tDCS group<br>* Sham tDCS will involve the same preparation as in tDCS, but the current will ramp up for only 30 seconds and then return to zero. This method allows for sensations on the scalp associated with tDCS without inducing any neural changes.<br>|
| Active Comparator: Computer cognitive training and tDCS group<br>Each session will consist of 20 minutes of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. This will be followed by 45 minutes of the assigned computer cognitive training. | Device: tDCS<br>* Each session will begin with 20 minutes of anodal tDCS applied to the ipsilesional dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. The cathode will be placed over the contralesional supraorbital area. Direct current will be applied through two saline soaked sponges placed on the scalp. The tDCS device contains software for double-blinded delivery.<br>Behavioral: Computer Cognitive Training Procedures<br>* Individuals receiving computerized cognitive training will receive an equal dosage of 12, 45-minute sessions directly following the assigned tDCS condition. The online training software of BrainHQ will be used. BrainHQ is a well-recognized cognitive training program that targets the areas of attention, memory, processing speed, people skills, intelligence, and navigation. BrainHQ tracks progress and automatically grades difficulty as appropriate.<br>|
| Active Comparator: Computer cognitive training and sham tDCS group<br>Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training. | Behavioral: Computer Cognitive Training Procedures<br>* Individuals receiving computerized cognitive training will receive an equal dosage of 12, 45-minute sessions directly following the assigned tDCS condition. The online training software of BrainHQ will be used. BrainHQ is a well-recognized cognitive training program that targets the areas of attention, memory, processing speed, people skills, intelligence, and navigation. BrainHQ tracks progress and automatically grades difficulty as appropriate.<br>Device: sham tDCS group<br>* Sham tDCS will involve the same preparation as in tDCS, but the current will ramp up for only 30 seconds and then return to zero. This method allows for sensations on the scalp associated with tDCS without inducing any neural changes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to be randomized | Percent of eligible participants willing to be randomized | After study completion, an average of 5 weeks | 
| Recruitment | Number enrolled/number screened AND number recruited per month | After study completion, an average of 5 weeks | 
| Retention | Number completing study procedures/number enrolled | After study completion, an average of 5 weeks | 
| Adherence | Number of sessions attended/total number of sessions | After study completion, an average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 
| Performance Quality Rating Scale | Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 
| National Institutes of Health Toolbox Cognition Battery | Computerized measure of cognitive precesses (e.g. executive function, attention, working memory.) A crystalized intelligence composite T-score and fluid intelligence T-score with means of 100 and a standard deviation of 15 will be used in analysis. Higher scores represent better performance. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 
| Weekly Calendar Planning Assessment | Performance-based measure of executive function within a simulated calendar planning task. Level II will be used. Total appointments entered correctly and an efficiency score will be used in analysis. Higher scores represent better performance. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 
| Participation Strategies-Self-efficacy Scale (PS-SES) | Self-report measure of confidence in performing daily activities. It consists of 35 items in six domains. Each item is rated on a scale of 1 to 10 with higher scores representing greater self-efficacy. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 
| Stroke Impact Scale (SIS) - Participation domain | Self-report measure of participation in daily life activities. The participation domain consists of 8 items with resulting scores from 0 to 100 and higher scores representing higher levels of participation. | Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) | 

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