Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Sham rTMS; Device: Modified TBS rTMS; Device: Traditional Theta burst stimulation (TBS)

• Registration Number: NCT01855633
• Lead Sponsor: Dongtan Sacred Heart Hospital

Brief Summary

Stroke is one of the major causes of death in the World. Many stroke survivors may suffer from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy are limited. The development of new treatment strategies is essential. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area of the brain for restoring brain function. The aim of this study is to investigate the therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2039-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• stroke patients with motor weakness
• Medical research council (MRC) grade 0-4
• More than 2 weeks after stroke onset
• Age 18 years and older
• Able to provide consent for the protocol

Exclusion Criteria

• History of previous symptomatic stroke
• pregnant women
• Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded
• Patients with history of seizure disorder or epilepsy
• Subjects without the capacity to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	Sham rTMS	Participants will receive sham cTBS rTMS to contralesional hemisphere.
Modified TBS rTMS	Modified TBS rTMS	Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)
Tradtional Theta burst stimulation (TBS) rTMS	Traditional Theta burst stimulation (TBS)	Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)

Primary Outcome Measures

Name	Time	Method
Keyboard tapping test	1 day	Participants will be asked to tap a key of a computer keyboard as fast as possible in five seconds. They will be asked to do three times. We will measure the number of tapping. The primary outcome will be the averaged data of the numbers.This will be done before and after 5-day rTMS intervention.

Trial Locations

Locations (1)

Dongtan Sacred Heart Hospital; 🇰🇷 Hwaseong Si, Gyeonggi-Do, Korea, Republic of