tDCS and CO-OP in Chronic Stroke
Primary Purpose
Chronic Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS and CO-OP Group
Sponsored by

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
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)
Sites / Locations
- University of Missouri-Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tDCS and CO-OP Group
Arm Description
One-hour session three times per week for 4 weeks. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. Following each tDCS session, the participants will complete a sensations questionnaire.The basis for each session will be task-based practice of client-chosen goals and the use of cognitive strategies using CO-OP.
Outcomes
Primary Outcome Measures
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility
Semi-Structured Interview
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.
Client Satisfaction Questionnaire (CSQ-8)
Self-report, 8 item measures of intervention acceptability
Secondary Outcome Measures
Performance Quality Rating Scale (PQRS)
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).
Canadian Occupational Performance Measure (COPM)
Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale
Full Information
NCT ID
NCT04617548
First Posted
September 25, 2020
Last Updated
February 9, 2022
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04617548
Brief Title
tDCS and CO-OP in Chronic Stroke
Official Title
Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
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
Data Monitoring Committee
No
5. Study Description
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.
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
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS and CO-OP Group
Arm Type
Experimental
Arm Description
One-hour session three times per week for 4 weeks. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. Following each tDCS session, the participants will complete a sensations questionnaire.The basis for each session will be task-based practice of client-chosen goals and the use of cognitive strategies using CO-OP.
Intervention Type
Combination Product
Intervention Name(s)
tDCS and CO-OP Group
Other Intervention Name(s)
Brain Stimulation and Metacognitive Strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
Description
A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility
Time Frame
after study completion, an average of 5 weeks
Title
Semi-Structured Interview
Description
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.
Time Frame
after study completion, an average of 5 weeks
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Self-report, 8 item measures of intervention acceptability
Time Frame
after study completion, an average of 5 weeks
Secondary Outcome Measure Information:
Title
Performance Quality Rating Scale (PQRS)
Description
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).
Time Frame
Pre-intervention and post-intervention, typically an average of 5 weeks
Title
Canadian Occupational Performance Measure (COPM)
Description
Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale
Time Frame
Pre-intervention and post-intervention, typically an average of 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
652122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21440699
Citation
Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
Results Reference
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PubMed Identifier
17453976
Citation
Hartman-Maeir A, Soroker N, Ring H, Avni N, Katz N. Activities, participation and satisfaction one-year post stroke. Disabil Rehabil. 2007 Apr 15;29(7):559-66. doi: 10.1080/09638280600924996.
Results Reference
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PubMed Identifier
15753425
Citation
Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
Results Reference
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PubMed Identifier
19403329
Citation
Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28.
Results Reference
background
PubMed Identifier
25416738
Citation
McEwen S, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, Wolf T. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):526-36. doi: 10.1177/1545968314558602. Epub 2014 Nov 21.
Results Reference
background
PubMed Identifier
14580622
Citation
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Results Reference
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PubMed Identifier
16106673
Citation
Paulus W. Outlasting excitability shifts induced by direct current stimulation of the human brain. Suppl Clin Neurophysiol. 2004;57:708-14. doi: 10.1016/s1567-424x(09)70411-8.
Results Reference
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PubMed Identifier
20607750
Citation
Polania R, Nitsche MA, Paulus W. Modulating functional connectivity patterns and topological functional organization of the human brain with transcranial direct current stimulation. Hum Brain Mapp. 2011 Aug;32(8):1236-49. doi: 10.1002/hbm.21104. Epub 2010 Jul 6.
Results Reference
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PubMed Identifier
17452283
Citation
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Results Reference
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PubMed Identifier
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Citation
Richards LG, Latham NK, Jette DU, Rosenberg L, Smout RJ, DeJong G. Characterizing occupational therapy practice in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S51-S60. doi: 10.1016/j.apmr.2005.08.127.
Results Reference
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tDCS and CO-OP in Chronic Stroke
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