NCT03486808

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2018

Completed
Last Updated

September 20, 2019

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

March 22, 2018

Last Update Submit

September 19, 2019

Conditions

Keywords

transcranial direct current stimulationmotor function

Outcome Measures

Primary Outcomes (2)

  • Korean Boston naming test

    measures naming ability thorough picture naming test

    Baseline and after intervention (approximately 30 minutes)

  • Verbal 3 back test

    measure working memory

    Baseline and after intervention (approximately 30 minutes)

Secondary Outcomes (2)

  • Korean Color Word Stroop test

    Baseline and after intervention (approximately 30 minutes)

  • Controlled Oral Word Association Test

    Baseline and after intervention (approximately 30 minutes)

Study Arms (4)

Dual stimulation

EXPERIMENTAL

i) anodal stimulation of left inferior frontal cortex ii) anodal stimulation on left dorsolateral prefrontal cortex

Device: IFG stimulationDevice: DLPFC stimulation

IFG stimulation

ACTIVE COMPARATOR

anodal stimulation of left inferior frontal cortex

Device: IFG stimulation

DLPFC stimulation

ACTIVE COMPARATOR

anodal stimulation on left dorsolateral prefrontal cortex

Device: DLPFC stimulation

Sham stimulation

SHAM COMPARATOR

sham stimulation

Device: Sham stimulation

Interventions

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

Dual stimulationIFG stimulation

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

DLPFC stimulationDual stimulation

sham stimulation over both left inferior frontal cortex and dorsolateral prefrontal cortex

Sham stimulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects with age over 19 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

February 28, 2018

Primary Completion

May 22, 2018

Study Completion

May 22, 2018

Last Updated

September 20, 2019

Record last verified: 2018-03

Locations