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

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ClinicalTrials.gov Identifier: NCT03647345
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment
Actual Study Start Date : April 30, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Experimental 1: Anodal Dual-mode stimulation

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

Experimental: Experimental 2: Cathodal Dual-mode stimulation

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

Active Comparator: Active Comparator: Single sham stimulation

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




Primary Outcome Measures :
  1. Accuracy of 2-back verbal working memory task [ Time Frame: Change from Pre-intervention at 2 months ]
    Accuracy (percentile) of 2-back verbal working memory task



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647345


Contacts
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Contact: Yun-Hee Kim, MD, PhD +82-2-3410-2818 yun1225.kim@samsung.com
Contact: Ahee Lee, MD +82-2-3410-2832 ahee.lee@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yunkim@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03647345     History of Changes
Other Study ID Numbers: 2015-01-132-005
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Samsung Medical Center:
Noninvasive brain stimulation
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders