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

May 10, 2013
September 23, 2013
April 2013
April 2016   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01855633 on ClinicalTrials.gov Archive Site
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Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stroke
  • Device: Traditional Theta burst stimulation (TBS)
  • Device: Modified TBS rTMS
  • Device: Sham rTMS
  • 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)
    Intervention: 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)
    Intervention: Device: Modified TBS rTMS
  • Sham Comparator: Sham rTMS
    Participants will receive sham cTBS rTMS to contralesional hemisphere.
    Intervention: Device: Sham rTMS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT01855633
2013-019
No
Suk Yun Kang, Dongtan Sacred Heart Hospital
Dongtan Sacred Heart Hospital
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Dongtan Sacred Heart Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP