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

Not Applicable

Completed

• Conditions: Cognitive Impairment; Stroke; Aphasia
• Interventions: Device: IFG stimulation; Device: DLPFC stimulation; Behavioral: aphasia therapy

• Registration Number: NCT03486782
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-04-01
• Study First Posted: 2018-04-03
• Study Start: 2018-05-29
• Status Verified: 2020-03
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• left hemisphere involved stroke patients
• patients diagnoses as post stroke aphasia

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Exclusion Criteria

• history of psychiatric disease
• patients with metal implants
• history of epilepsy
• pregnancy
• skin defect at the site of electrode attachment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual stimulation	IFG stimulation	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
Dual stimulation	aphasia therapy	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
Single stimulation 1	IFG stimulation	i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex
Single stimulation 2	aphasia therapy	i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area
Dual stimulation	DLPFC stimulation	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
Single stimulation 1	aphasia therapy	i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex
Single stimulation 2	IFG stimulation	i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

Primary Outcome Measures

Name	Time	Method
Changes in Korean Western Aphasia Battery	Baseline and after intervention (approximately 2 weeks)	assessment of language function and provide aphasia quotients
Changes in Korean Boston naming test	Baseline and after intervention (approximately 2 weeks)	measures naming ability thorough picture naming test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of