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tDCS and CO-OP in Chronic Stroke

Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04617548
Enrollment
8
Registered
2020-11-05
Start date
2020-01-01
Completion date
2022-01-01
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke

Keywords

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

Brief summary

This project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tDCS) and metacognitive strategy training (MCST) in individuals with chronic stroke.

Detailed description

Currently seven million people are living in the United States post stroke, making stroke the leading cause of long term disability. Almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. This is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. The rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. Metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. Participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. Metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. Transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. While it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. Combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

Interventions

COMBINATION_PRODUCTtDCS and CO-OP Group

Transcranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. 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.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* \> 6 months post mild to moderate ischemic stroke * self-reported functional limitations * Age 30-80

Exclusion criteria

* history of other neurological diagnoses * cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment) * severe aphasia (greater than or equal to 2 on the NIHSS language item * non-English speaking * any additional condition where the PI deems participation unsafe * pregnancy, 7) * history of seizures * medications that influence cortical excitability * metallic implants above the chest * history of welding or metalwork * severe depressive symptoms (\>21 on Patient Health Questionnaire)

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measureafter study completion, an average of 5 weeksA brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility
Semi-Structured Interviewafter study completion, an average of 5 weeksA brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention.
Client Satisfaction Questionnaire (CSQ-8)after study completion, an average of 5 weeksSelf-report, 8 item measures of intervention acceptability

Secondary

MeasureTime frameDescription
Performance Quality Rating Scale (PQRS)Pre-intervention and post-intervention, typically an average of 5 weeksAn objective measure of participant performance of goals. Each goal is rated by a trained observer from 1 (no activity criteria were met) and 10 (all activity criteria were met).
Canadian Occupational Performance Measure (COPM)Pre-intervention and post-intervention, typically an average of 5 weeksSelf-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026