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

Samsung Medical Center

Status: Completed

Conditions: Stroke; Motor Disorder

Treatments: Device: tDCS on contralesional M1; Device: rTMS on ipsilesional M1

Study type: Interventional

Funder types: Other

Identifiers

NCT03279640

2013-06-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Dual-mode stimulation

Experimental group

Description:

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.

Treatment:

Device: tDCS on contralesional M1

Device: rTMS on ipsilesional M1

Single stimulation

Experimental group

Description:

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.

Treatment:

Device: rTMS on ipsilesional M1