NCT03647345

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of mild cognitive impairment (MCI) patients' cognitive function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in MCI patients. In this study, simultaneous stimulation using both facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in mild cognitive impairment patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

April 26, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

January 3, 2018

Last Update Submit

September 19, 2019

Conditions

Mild Cognitive Impairment

Keywords

Noninvasive brain stimulationRepetitive Transcranial Magnetic StimulationTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Accuracy of 2-back verbal working memory task

    Accuracy (percentile) of 2-back verbal working memory task

    Change from Pre-intervention at 2 months

Study Arms (3)

Experimental 1: Anodal Dual-mode stimulation

EXPERIMENTAL

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of anodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC

Experimental 2: Cathodal Dual-mode stimulation

EXPERIMENTAL

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of cathodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC

Active Comparator: Single sham stimulation

ACTIVE COMPARATOR

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC

Interventions

High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFCDEVICE

10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.

Experimental 1: Anodal Dual-mode stimulation
High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFCDEVICE

10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.

Experimental 2: Cathodal Dual-mode stimulation
High-frequency rTMS on left DLPFC+sham tDCS on right DLPFCDEVICE

10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.

Active Comparator: Single sham stimulation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild cognitive impairment diagnosed via a history, a neurocognitive test, and brain imaging

You may not qualify if:

  • K-MMSE score under 9
  • Major active neurological disease or psychiatric disease
  • A history of seizure
  • Metallic implants in their brain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

August 27, 2018

Study Start

April 26, 2015

Primary Completion

July 5, 2018

Study Completion

July 5, 2018

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)