tDCS and Metacognitive Strategy Training in Stroke

Not Applicable

Terminated

• Conditions: Chronic Stroke

• Registration Number: NCT05248178
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study Start: 2022-01-31
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2025-06
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Performance Quality Rating Scale	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
National Institutes of Health Toolbox Cognition Battery	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	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.
Weekly Calendar Planning Assessment	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	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.
Stroke Impact Scale (SIS) - Participation domain	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	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.
Participation Strategies-Self-efficacy Scale (PS-SES)	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)	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.

Trial Locations

Locations (1)

University of Missouri Occupational Therapy Department; 🇺🇸 Columbia, Missouri, United States