Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

Samsung Medical Center

Status: Completed

Conditions: Stroke

Treatments: Device: Dual-mode stimulation; Device: Single sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03390192

2013-06-002-009

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 inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.

Enrollment: 43 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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: Single Blind

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43 participants in 2 patient groups

Dual-mode stimulation

Experimental group

Description:

Dual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional 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: Dual-mode stimulation

Single sham stimulation

Active Comparator group

Description:

Single sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional 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: Single sham stimulation