tDCS and Metacognitive Strategy Training in Stroke

NCT05248178 | Terminated FDA Device

• 1 other identifier: 2076763
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Stroke; Metacognitive Strategy Training; Brain Stimulation; CO-OP; tDCS

Outcome Measures

Primary Outcomes (4)

• Willingness to be randomized

  Percent of eligible participants willing to be randomized

  After study completion, an average of 5 weeks

• Recruitment

  Number enrolled/number screened AND number recruited per month

  After study completion, an average of 5 weeks

• Retention

  Number completing study procedures/number enrolled

  After study completion, an average of 5 weeks

• Adherence

  Number of sessions attended/total number of sessions

  After study completion, an average of 5 weeks

Secondary Outcomes (6)

• 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)

• Participation Strategies-Self-efficacy Scale (PS-SES)

  Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

Study Arms (4)

CO-OP and tDCS group

EXPERIMENTAL

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; Device: tDCS

CO-OP and sham tDCS group

ACTIVE COMPARATOR

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

Behavioral: CO-OP Procedures; Device: sham tDCS group

Computer cognitive training and tDCS group

ACTIVE COMPARATOR

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; Behavioral: Computer Cognitive Training Procedures

Computer cognitive training and sham tDCS group

ACTIVE COMPARATOR

Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.

Behavioral: Computer Cognitive Training Procedures; Device: sham tDCS group

Interventions

CO-OP Procedures 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.

CO-OP and sham tDCS group; CO-OP and tDCS group

tDCS 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 tDCS group; Computer cognitive training and tDCS group

Computer Cognitive Training Procedures 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; Computer cognitive training and tDCS group

sham tDCS group 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.

CO-OP and sham tDCS group; Computer cognitive training and sham tDCS group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>6 months post-ischemic stroke
• not currently receiving therapy services
• a minimum of four self-identified functional goals

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Occupational Therapy Department

Columbia, Missouri, 65203, United States

Location

Related Publications (52)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Anna E Boone, PhD, OTR/L

  University of Missouri Occupational Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Department of Occupational Therapy

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: January 31, 2022
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)