tDCS and Metacognitive Strategy Training in Stroke

NCT ID: NCT05248178

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2025-06-11

Brief Summary

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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

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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.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.)

Study Groups

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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.

Group Type EXPERIMENTAL

CO-OP Procedures

Intervention Type BEHAVIORAL

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.

tDCS

Intervention Type DEVICE

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.

CO-OP and sham tDCS group

Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.

Group Type ACTIVE_COMPARATOR

CO-OP Procedures

Intervention Type BEHAVIORAL

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.

sham tDCS group

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

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.

Computer Cognitive Training Procedures

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Computer Cognitive Training Procedures

Intervention Type BEHAVIORAL

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.

sham tDCS group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Anna Boone

Assistant Professor in the Department of Occupational Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna E Boone, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Occupational Therapy

Locations

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University of Missouri Occupational Therapy Department

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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Other Identifiers

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2076763

Identifier Type: -

Identifier Source: org_study_id

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