CClinicalTrials.gg
CompletedNCT03486808Updated Sep 20, 2019

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

An interventional study of IFG stimulation and DLPFC stimulation in Healthy, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • transcranial direct current stimulation
  • motor function
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy subjects with age over 19 years old

Exclusion criteria

Exclusion Criteria:

  • history of disorders involving central nervous system
  • patients with severe medical or psychiatric disease
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Dual stimulation

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

    Device: IFG stimulation · Device: DLPFC stimulation

  • Active comparator
    IFG stimulation

    anodal stimulation of left inferior frontal cortex

    Device: IFG stimulation

  • Active comparator
    DLPFC stimulation

    anodal stimulation on left dorsolateral prefrontal cortex

    Device: DLPFC stimulation

  • Sham comparator
    Sham stimulation

    sham stimulation

    Device: Sham stimulation

Interventions

  • DeviceIFG stimulation

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

  • DeviceDLPFC stimulation

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

  • DeviceSham stimulation

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

05

What researchers measure

Primary outcomes

  1. Korean Boston naming test

    measures naming ability thorough picture naming test

    Time frame: Baseline and after intervention (approximately 30 minutes)

  2. Verbal 3 back test

    measure working memory

    Time frame: Baseline and after intervention (approximately 30 minutes)

Secondary outcomes

  1. Korean Color Word Stroop test

    measures selective attention and executive function

    Time frame: Baseline and after intervention (approximately 30 minutes)

  2. Controlled Oral Word Association Test

    measure verbal fluency

    Time frame: Baseline and after intervention (approximately 30 minutes)

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03486808
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Feb 28, 2018
Primary completion
May 22, 2018
Completion
May 22, 2018
Last update
Sep 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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