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Completed

NCT Number: NCT04617548

tDCS and CO-OP in Chronic Stroke

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.

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Key information

Conditions

Chronic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Missouri-Columbia

Columbia, Missouri, 652122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tDCS and CO-OP Group

Combination Product

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.

Other names: Brain Stimulation and Metacognitive Strategy

Primary outcomes

  1. Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure

    Time frame: after study completion, an average of 5 weeks

    A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility

  2. Semi-Structured Interview

    Time frame: after study completion, an average of 5 weeks

    A 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.

  3. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: after study completion, an average of 5 weeks

    Self-report, 8 item measures of intervention acceptability

Secondary outcomes

  1. Performance Quality Rating Scale (PQRS)

    Time frame: Pre-intervention and post-intervention, typically an average of 5 weeks

    An 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).

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: Pre-intervention and post-intervention, typically an average of 5 weeks

    Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 5, 2020
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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