tDCS and Metacognitive Strategy Training in Stroke

April 22, 2026 updated by: Anna Boone, University of Missouri-Columbia

Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri Occupational Therapy Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: CO-OP Procedures
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.
Device: tDCS
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.
Active Comparator: CO-OP and sham tDCS group
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.
Behavioral: CO-OP Procedures
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.
Device: sham tDCS group
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.
Active Comparator: 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.
Device: tDCS
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.
Behavioral: Computer Cognitive Training Procedures
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.
Active Comparator: 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.
Device: sham tDCS group
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.
Behavioral: Computer Cognitive Training Procedures
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to be randomized
Time Frame: After study completion, an average of 5 weeks
Percent of eligible participants willing to be randomized
After study completion, an average of 5 weeks
Recruitment
Time Frame: After study completion, an average of 5 weeks
Number enrolled/number screened AND number recruited per month
After study completion, an average of 5 weeks
Retention
Time Frame: After study completion, an average of 5 weeks
Number completing study procedures/number enrolled
After study completion, an average of 5 weeks
Adherence
Time Frame: After study completion, an average of 5 weeks
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
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Performance Quality Rating Scale
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
National Institutes of Health Toolbox Cognition Battery
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Weekly Calendar Planning Assessment
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Participation Strategies-Self-efficacy Scale (PS-SES)
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Stroke Impact Scale (SIS) - Participation domain
Time Frame: 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.
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

June 11, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2076763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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