Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

NCT ID: NCT01855633

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2040-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tradtional Theta burst stimulation (TBS) rTMS

Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)

Group Type EXPERIMENTAL

Traditional Theta burst stimulation (TBS)

Intervention Type DEVICE

Modified TBS rTMS

Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)

Group Type ACTIVE_COMPARATOR

Modified TBS rTMS

Intervention Type DEVICE

Sham rTMS

Participants will receive sham cTBS rTMS to contralesional hemisphere.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Interventions

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Traditional Theta burst stimulation (TBS)

Intervention Type DEVICE

Modified TBS rTMS

Intervention Type DEVICE

Sham rTMS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongtan Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suk Yun Kang

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Suk Yun Kang, MD, PhD

Role: CONTACT

82-31-8086-2310

Ah-Young Jun, MD, MS

Role: CONTACT

82-31-8086-2310

Facility Contacts

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Suk Yun Kang, MD, PhD

Role: primary

82-31-8086-2310

Ah-Young Jun, MD, MS

Role: backup

82-31-8086-2310

Other Identifiers

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2013-019

Identifier Type: -

Identifier Source: org_study_id

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