Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Dual-mode stimulation; Device: Single sham stimulation

• Registration Number: NCT03390192
• 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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-13
• Status Verified: 2017-12
• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-04
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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	Dual-mode stimulation	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.
Single sham stimulation	Single sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment score	2 months post-stimulation	Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of