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tDCS and Metacognitive Strategy Training in Stroke

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO-OP Procedures
tDCS
Computer Cognitive Training Procedures
sham tDCS group
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Stroke, Metacognitive Strategy Training, Brain Stimulation, CO-OP, tDCS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri Occupational Therapy DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

CO-OP and tDCS group

CO-OP and sham tDCS group

Computer cognitive training and tDCS group

Computer cognitive training and sham tDCS group

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

Willingness to be randomized
Percent of eligible participants willing to be randomized
Recruitment
Number enrolled/number screened AND number recruited per month
Retention
Number completing study procedures/number enrolled
Adherence
Number of sessions attended/total number of sessions

Secondary Outcome Measures

Canadian Occupational Performance Measure
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Performance Quality Rating Scale
Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
National Institutes of Health Toolbox Cognition Battery
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.
Weekly Calendar Planning Assessment
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.
Participation Strategies-Self-efficacy Scale (PS-SES)
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.
Stroke Impact Scale (SIS) - Participation domain
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.

Full Information

First Posted
February 9, 2022
Last Updated
April 6, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05248178
Brief Title
tDCS and Metacognitive Strategy Training in Stroke
Official Title
Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Stroke, Metacognitive Strategy Training, Brain Stimulation, CO-OP, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CO-OP and tDCS group
Arm Type
Experimental
Arm Description
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.
Arm Title
CO-OP and sham tDCS group
Arm Type
Active Comparator
Arm Description
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.
Arm Title
Computer cognitive training and tDCS group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Computer cognitive training and sham tDCS group
Arm Type
Active Comparator
Arm Description
Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.
Intervention Type
Behavioral
Intervention Name(s)
CO-OP Procedures
Intervention Description
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
Device
Intervention Name(s)
tDCS
Intervention Description
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
Behavioral
Intervention Name(s)
Computer Cognitive Training Procedures
Intervention Description
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
Device
Intervention Name(s)
sham tDCS group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Willingness to be randomized
Description
Percent of eligible participants willing to be randomized
Time Frame
After study completion, an average of 5 weeks
Title
Recruitment
Description
Number enrolled/number screened AND number recruited per month
Time Frame
After study completion, an average of 5 weeks
Title
Retention
Description
Number completing study procedures/number enrolled
Time Frame
After study completion, an average of 5 weeks
Title
Adherence
Description
Number of sessions attended/total number of sessions
Time Frame
After study completion, an average of 5 weeks
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Title
Performance Quality Rating Scale
Description
Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Title
National Institutes of Health Toolbox Cognition Battery
Description
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.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Title
Weekly Calendar Planning Assessment
Description
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.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Title
Participation Strategies-Self-efficacy Scale (PS-SES)
Description
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.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Title
Stroke Impact Scale (SIS) - Participation domain
Description
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.
Time Frame
Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna E Boone, PhD, OTR/L
Phone
573-882-7023
Email
booneae@umsystem.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna E Boone, PhD, OTR/L
Organizational Affiliation
University of Missouri Occupational Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Occupational Therapy Department
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna E Boone, PhD, OTR/L
Phone
573-882-7023
Email
booneae@umsystem.edu
First Name & Middle Initial & Last Name & Degree
Anna E Boone, PhD, OTR/L

12. IPD Sharing Statement

Plan to Share IPD
No
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tDCS and Metacognitive Strategy Training in Stroke

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