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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC; Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC; Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC

• Registration Number: NCT03647345
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-26
• Study First Submitted: 2018-01-03
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 2: Cathodal Dual-mode stimulation	High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC	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.
Active Comparator: Single sham stimulation	High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC	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.
Experimental 1: Anodal Dual-mode stimulation	High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of 2-back verbal working memory task	Change from Pre-intervention at 2 months	Accuracy (percentile) of 2-back verbal working memory task

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of