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

Study Overview
=================
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.

Official Title
-----------------
Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study

Conditions
-----------------
Stroke, Motor Disorder

Intervention / Treatment
-----------------
* Device: rTMS on ipsilesional M1
* Device: tDCS on contralesional M1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-ever stroke patients Subacute stage (less than 4 weeks) Total Fugl-Meyer Assessment (FMA) score under 84 Exclusion Criteria: Major active neurological disease or psychiatric disease A history of seizure Metallic implants in their brain

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-mode stimulation<br>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. | Device: rTMS on ipsilesional M1<br> <br> Device: tDCS on contralesional M1<br> <br> |
| Experimental: Single stimulation<br>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. | Device: rTMS on ipsilesional M1<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroimaging Assessment | Resting-state fMRI | Change from baseline resting-state brain network at 8 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor Network, Resting-state fMRI, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation