Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Post-stroke Cognitive Impairment

NCT ID: NCT03647319

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-11

Study Completion Date

2016-11-10

Brief Summary

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Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of post-stroke cognitive impairment 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 stroke 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 post-stroke cognitive impairment patients.

Detailed Description

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Conditions

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Post-stroke Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Who can perform the 2-back verbal and non-verbal working memory task

Exclusion Criteria

* K-MMSE score under 9
* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-06-002-016

Identifier Type: -

Identifier Source: org_study_id

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