Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients

Not Applicable

Completed

• Conditions: Motor Disorder; Stroke
• Interventions: Device: rTMS on ipsilesional M1; Device: tDCS on contralesional M1

• Registration Number: NCT03279640
• Lead Sponsor: Samsung Medical Center

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor 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 rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.

Detailed Description

Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-06
• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2017-09-10
• Study First Posted: 2017-09-12
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• First-ever stroke patients
• Subacute stage (less than 4 weeks)
• Total Fugl-Meyer Assessment (FMA) score under 84

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Exclusion Criteria

• Major active neurological disease or psychiatric disease
• A history of seizure
• Metallic implants in their brain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual-mode stimulation	tDCS on contralesional M1	rTMS on ipsilesional M1 + tDCS on contralesional M1 10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
Dual-mode stimulation	rTMS on ipsilesional M1	rTMS on ipsilesional M1 + tDCS on contralesional M1 10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.
Single stimulation	rTMS on ipsilesional M1	rTMS on ipsilesional M1 10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

Primary Outcome Measures

Name	Time	Method
Neuroimaging Assessment	Change from baseline resting-state brain network at 8 weeks after intervention	Resting-state fMRI