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

NCT ID: NCT03486782

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2020-03-17

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.

Detailed Description

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Conditions

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Stroke Aphasia Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dual 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

Group Type ACTIVE_COMPARATOR

IFG stimulation

Intervention Type DEVICE

stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

DLPFC stimulation

Intervention Type DEVICE

stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes

aphasia therapy

Intervention Type BEHAVIORAL

aphasia therapy for 30 minutes during transcranial direct current stimulation

Single stimulation 1

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex

Group Type ACTIVE_COMPARATOR

IFG stimulation

Intervention Type DEVICE

stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

aphasia therapy

Intervention Type BEHAVIORAL

aphasia therapy for 30 minutes during transcranial direct current stimulation

Single stimulation 2

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

Group Type ACTIVE_COMPARATOR

IFG stimulation

Intervention Type DEVICE

stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

aphasia therapy

Intervention Type BEHAVIORAL

aphasia therapy for 30 minutes during transcranial direct current stimulation

Interventions

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IFG stimulation

stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

Intervention Type DEVICE

DLPFC stimulation

stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes

Intervention Type DEVICE

aphasia therapy

aphasia therapy for 30 minutes during transcranial direct current stimulation

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-08-124-B

Identifier Type: -

Identifier Source: org_study_id

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