Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Stroke Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01855633
• Other study ID #: 2013-019
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2040

Study information

• Verified date: September 2023
• Source: Dongtan Sacred Heart Hospital
• Contact: Suk Yun Kang, MD, PhD
• Phone: 82-31-8086-2310
• Email: sukyunkang[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2040
• Est. primary completion date: December 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Traditional Theta burst stimulation (TBS)

• Modified TBS rTMS

• Sham rTMS

Locations

Country	Name	City	State
Korea, Republic of	Dongtan Sacred Heart Hospital	Hwaseong Si	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Dongtan Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keyboard tapping test	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.	1 day