tDCS and CO-OP in Chronic Stroke

University of Missouri (MU)

Status and phase: Completed; Phase 1

Conditions: Chronic Stroke

Treatments: Combination Product: tDCS and CO-OP Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04617548

2009451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

tDCS and CO-OP Group

Experimental group

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.

Treatment:

Combination Product: tDCS and CO-OP Group