Clinical trial NCT05248178: tDCS and Metacognitive Strategy Training in Stroke
Official title: Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Stroke
Keywords: Stroke
Metacognitive Strategy Training
Brain Stimulation
CO-OP
tDCS
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Willingness to be randomized
timeFrame: After study completion, an average of 5 weeks
measure: Recruitment
timeFrame: After study completion, an average of 5 weeks
measure: Retention
timeFrame: After study completion, an average of 5 weeks
measure: Adherence
timeFrame: After study completion, an average of 5 weeks
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
measure: Performance Quality Rating Scale
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
measure: National Institutes of Health Toolbox Cognition Battery
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
measure: Weekly Calendar Planning Assessment
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
measure: Participation Strategies-Self-efficacy Scale (PS-SES)
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
measure: Stroke Impact Scale (SIS) - Participation domain
timeFrame: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Occupational Therapy Department
state: Missouri
Study officials:
affiliation: University of Missouri Occupational Therapy
name: Anna E Boone, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
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