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

May 25, 2020 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Korean Boston naming test
Time Frame: Baseline and after intervention (approximately 2 weeks)
measures naming ability thorough picture naming test
Baseline and after intervention (approximately 2 weeks)
Changes in Korean Western Aphasia Battery
Time Frame: Baseline and after intervention (approximately 2 weeks)
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
Time Frame: Baseline and after intervention (approximately 2 weeks)
measures memory span
Baseline and after intervention (approximately 2 weeks)
Korea Montreal Cognitive Assessment
Time Frame: Baseline and after intervention (approximately 2 weeks)
measure cognitive function
Baseline and after intervention (approximately 2 weeks)
Korean Color Word Stroop test
Time Frame: Baseline and after intervention (approximately 2 weeks)
measures selective attention and executive function
Baseline and after intervention (approximately 2 weeks)
Controlled Oral Word Association Test
Time Frame: Baseline and after intervention (approximately 2 weeks)
measure verbal fluency
Baseline and after intervention (approximately 2 weeks)
Changes of Cortical activation
Time Frame: Baseline and after intervention (approximately 2 weeks)
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
Time Frame: Baseline and after intervention (approximately 2 weeks)
Neuroplasticity measure
Baseline and after intervention (approximately 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2018

Primary Completion (Actual)

March 17, 2020

Study Completion (Actual)

March 17, 2020

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 1, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-08-124-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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