Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

September 6, 2023 updated by: Suk Yun Kang, Dongtan Sacred Heart Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • Hwaseong Si, Gyeonggi-Do, Korea, Republic of, 445-170
        • Recruiting
        • Dongtan Sacred Heart Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suk Yun Kang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Device: Traditional Theta burst stimulation (TBS)
Active Comparator: Modified TBS rTMS
Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)
Device: Modified TBS rTMS
Sham Comparator: Sham rTMS
Participants will receive sham cTBS rTMS to contralesional hemisphere.
Device: Sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keyboard tapping test
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongtan Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimated)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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