Dual Site-Dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Healthy Subjects

September 19, 2019 updated by: Samsung Medical Center

Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Healthy Subjects

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 healthy. 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 left inferior frontal cortex, ii) anodal stimulation on left dorsolateral prefrontal cortex. 2) IFG stimulation: anodal stimulation on left inferior frontal cortex; 3) DLPFC stimulation: anodal stimulation on left dorsolateral prefrontal cortex area. 4) sham stimulation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects with age over 19 years old

Exclusion Criteria:

  • history of disorders involving central nervous system
  • patients with severe medical or psychiatric disease

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual stimulation
i) anodal stimulation of left inferior frontal cortex ii) anodal stimulation on left dorsolateral prefrontal cortex
Device: IFG stimulation
stimulating left inferior frontal cortex with transcranial direct current stimulation for 30 minutes
Device: DLPFC stimulation
stimulating left dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes
Active Comparator: IFG stimulation
anodal stimulation of left inferior frontal cortex
Device: IFG stimulation
stimulating left inferior frontal cortex with transcranial direct current stimulation for 30 minutes
Active Comparator: DLPFC stimulation
anodal stimulation on left dorsolateral prefrontal cortex
Device: DLPFC stimulation
stimulating left dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes
Sham Comparator: Sham stimulation
sham stimulation
Device: Sham stimulation
sham stimulation over both left inferior frontal cortex and dorsolateral prefrontal cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean Boston naming test
Time Frame: Baseline and after intervention (approximately 30 minutes)
measures naming ability thorough picture naming test
Baseline and after intervention (approximately 30 minutes)
Verbal 3 back test
Time Frame: Baseline and after intervention (approximately 30 minutes)
measure working memory
Baseline and after intervention (approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean Color Word Stroop test
Time Frame: Baseline and after intervention (approximately 30 minutes)
measures selective attention and executive function
Baseline and after intervention (approximately 30 minutes)
Controlled Oral Word Association Test
Time Frame: Baseline and after intervention (approximately 30 minutes)
measure verbal fluency
Baseline and after intervention (approximately 30 minutes)

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)

February 28, 2018

Primary Completion (Actual)

May 22, 2018

Study Completion (Actual)

May 22, 2018

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)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-08-124-D

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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