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Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC
High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC
High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Experimental 1: Anodal Dual-mode stimulation

Experimental 2: Cathodal Dual-mode stimulation

Active Comparator: Single sham stimulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2018
Last Updated
September 19, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03647345
Brief Title
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment
Official Title
Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2015 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental 1: Anodal Dual-mode stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental 2: Cathodal Dual-mode stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator: Single sham stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC
Intervention Description
10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.
Intervention Type
Device
Intervention Name(s)
High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC
Intervention Description
10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.
Intervention Type
Device
Intervention Name(s)
High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC
Intervention Description
10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.
Primary Outcome Measure Information:
Title
Accuracy of 2-back verbal working memory task
Description
Accuracy (percentile) of 2-back verbal working memory task
Time Frame
Change from Pre-intervention at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with mild cognitive impairment diagnosed via a history, a neurocognitive test, and brain imaging Exclusion Criteria: K-MMSE score under 9 Major active neurological disease or psychiatric disease A history of seizure Metallic implants in their brain
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Mild Cognitive Impairment

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