tDCS and Metacognitive Strategy Training in Stroke

University of Missouri (MU)

Status

Terminated

Conditions

Chronic Stroke

Treatments

Device: tDCS

Behavioral: Computer Cognitive Training Procedures

Device: sham tDCS group

Behavioral: CO-OP Procedures

Study type

Interventional

Funder types

Other

Identifiers

NCT05248178

2076763

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

11 participants in 4 patient groups

CO-OP and tDCS group

Experimental group

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.

Treatment:

Behavioral: CO-OP Procedures

Device: tDCS

CO-OP and sham tDCS group

Active Comparator group

Description:

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

Treatment:

Behavioral: CO-OP Procedures

Device: sham tDCS group

Computer cognitive training and tDCS group

Active Comparator group

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.

Treatment:

Behavioral: Computer Cognitive Training Procedures

Device: tDCS

Computer cognitive training and sham tDCS group

Active Comparator group

Description:

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

Treatment:

Device: sham tDCS group

Behavioral: Computer Cognitive Training Procedures