tDCS and Metacognitive Strategy Training in Stroke

Chronic Stroke Clinical Trial

Official title:

Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248178
• Other study ID #: 2076763
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Anna E Boone, PhD, OTR/L
• Phone: 573-882-7023
• Email: booneae[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• CO-OP Procedures
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.

Device:
• tDCS
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.

Behavioral:
• Computer Cognitive Training Procedures
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.

Device:
• sham tDCS group
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.

Locations

Country	Name	City	State
United States	University of Missouri Occupational Therapy Department	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to be randomized	Percent of eligible participants willing to be randomized	After study completion, an average of 5 weeks
Primary	Recruitment	Number enrolled/number screened AND number recruited per month	After study completion, an average of 5 weeks
Primary	Retention	Number completing study procedures/number enrolled	After study completion, an average of 5 weeks
Primary	Adherence	Number of sessions attended/total number of sessions	After study completion, an average of 5 weeks
Secondary	Canadian Occupational Performance Measure	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Secondary	Performance Quality Rating Scale	Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Secondary	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.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Secondary	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.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Secondary	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.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)
Secondary	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.	Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)