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

Samsung Medical Center

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC; Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC; Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC

Study type: Interventional

Funder types: Other

Identifiers

NCT03647345

2015-01-132-005

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

21 participants in 3 patient groups

Experimental 1: Anodal Dual-mode stimulation

Experimental group

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.

Treatment:

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

Experimental 2: Cathodal Dual-mode stimulation

Experimental group

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.

Treatment:

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

Active Comparator: Single sham stimulation

Active Comparator group

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.

Treatment:

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