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Completed

NCT Number: NCT03647345

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

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

Device

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

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

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Investigation for Individualized Noninvasive Neuromodulation in Mild Cognitive Impairment

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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