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

Study Overview
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Brief Summary
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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.

Official Title
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Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC
* Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC
* Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1: Anodal Dual-mode stimulation<br>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<br>* 10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.<br>|
| Experimental: Experimental 2: Cathodal Dual-mode stimulation<br>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<br>* 10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.<br>|
| Active Comparator: Active Comparator: Single sham stimulation<br>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<br>* 10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of 2-back verbal working memory task | Accuracy (percentile) of 2-back verbal working memory task | Change from Pre-intervention at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive brain stimulation, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation