Dual Site-dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Stroke Patients

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.

Official Title
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Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Stroke Patients

Conditions
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Stroke, Aphasia, Cognitive Impairment

Intervention / Treatment
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* Device: IFG stimulation
* Device: DLPFC stimulation
* Behavioral: aphasia therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: left hemisphere involved stroke patients patients diagnoses as post stroke aphasia Exclusion Criteria: history of psychiatric disease patients with metal implants history of epilepsy pregnancy skin defect at the site of electrode attachment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dual stimulation<br>i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area | Device: IFG stimulation<br>* stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes<br>Device: DLPFC stimulation<br>* stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes<br>Behavioral: aphasia therapy<br>* aphasia therapy for 30 minutes during transcranial direct current stimulation<br>|
| Active Comparator: Single stimulation 1<br>i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex | Device: IFG stimulation<br>* stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes<br>Behavioral: aphasia therapy<br>* aphasia therapy for 30 minutes during transcranial direct current stimulation<br>|
| Active Comparator: Single stimulation 2<br>i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area | Device: IFG stimulation<br>* stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes<br>Behavioral: aphasia therapy<br>* aphasia therapy for 30 minutes during transcranial direct current stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Korean Boston naming test | measures naming ability thorough picture naming test | Baseline and after intervention (approximately 2 weeks) | 
| Changes in Korean Western Aphasia Battery | assessment of language function and provide aphasia quotients | Baseline and after intervention (approximately 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digit span test | measures memory span | Baseline and after intervention (approximately 2 weeks) | 
| Korea Montreal Cognitive Assessment | measure cognitive function | Baseline and after intervention (approximately 2 weeks) | 
| Korean Color Word Stroop test | measures selective attention and executive function | Baseline and after intervention (approximately 2 weeks) | 
| Controlled Oral Word Association Test | measure verbal fluency | Baseline and after intervention (approximately 2 weeks) | 
| Changes of Cortical activation | Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) | Baseline and after intervention (approximately 2 weeks) | 
| Changes in brain activation of resting-state and task functional MRI | Neuroplasticity measure | Baseline and after intervention (approximately 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, dual stimulation