Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Willingness to be randomized
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
All outcome assessors will be blinded to participant study group assignment. Participants and investigative team will be blinded to participant tDCS condition (i.e. active vs sham.)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CO-OP and tDCS group
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.
Intervention: CO-OP Procedures (Behavioral)
CO-OP and tDCS group
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.
Intervention: tDCS (Device)
CO-OP and sham tDCS group
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.
Intervention: CO-OP Procedures (Behavioral)
CO-OP and sham tDCS group
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.
Intervention: sham tDCS group (Device)
Computer cognitive training and tDCS group
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.
Intervention: tDCS (Device)
Computer cognitive training and tDCS group
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.
Intervention: Computer Cognitive Training Procedures (Behavioral)
Computer cognitive training and sham tDCS group
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.
Intervention: Computer Cognitive Training Procedures (Behavioral)
Computer cognitive training and sham tDCS group
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.
Intervention: sham tDCS group (Device)
Outcomes
Primary Outcomes
Willingness to be randomized
Time Frame: After study completion, an average of 5 weeks
Percent of eligible participants willing to be randomized
Recruitment
Time Frame: After study completion, an average of 5 weeks
Number enrolled/number screened AND number recruited per month
Retention
Time Frame: After study completion, an average of 5 weeks
Number completing study procedures/number enrolled
Adherence
Time Frame: After study completion, an average of 5 weeks
Number of sessions attended/total number of sessions
Secondary Outcomes
- Canadian Occupational Performance Measure(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
- Performance Quality Rating Scale(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
- National Institutes of Health Toolbox Cognition Battery(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
- Weekly Calendar Planning Assessment(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
- Stroke Impact Scale (SIS) - Participation domain(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
- Participation Strategies-Self-efficacy Scale (PS-SES)(Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9))
Investigators
Anna Boone
Assistant Professor in the Department of Occupational Therapy
University of Missouri-Columbia