Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Dongtan Sacred Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Suk Yun Kang, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01855633
First received: May 10, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Stroke
Device: Traditional Theta burst stimulation (TBS)
Device: Modified TBS rTMS
Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by Dongtan Sacred Heart Hospital:

Primary Outcome Measures:
  • Keyboard tapping test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855633

Contacts
Contact: Suk Yun Kang, MD, PhD 82-31-8086-2310 sukyunkang@hanmail.net
Contact: Ah-Young Jun, MD, MS 82-31-8086-2310 ayjun@hallym.or.kr

Locations
Korea, Republic of
Dongtan Sacred Heart Hospital Recruiting
Hwaseong Si, Gyeonggi-Do, Korea, Republic of, 445-170
Contact: Suk Yun Kang, MD, PhD    82-31-8086-2310    sukyunkang@hanmail.net   
Contact: Ah-Young Jun, MD, MS    82-31-8086-2310    ayjun@hallym.or.kr   
Principal Investigator: Suk Yun Kang, MD, PhD         
Sponsors and Collaborators
Dongtan Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: Suk Yun Kang, MD, PhD, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01855633     History of Changes
Other Study ID Numbers: 2013-019
Study First Received: May 10, 2013
Last Updated: September 23, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014