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Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Sponsor
Dongtan Sacred Heart Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01855633
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
140
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Traditional Theta burst stimulation (TBS)
  • Device: Modified TBS rTMS
  • Device: Sham rTMS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Keyboard tapping test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dongtan Sacred Heart Hospital Hwaseong Si Gyeonggi-Do Korea, Republic of 445-170

Sponsors and Collaborators

  • Dongtan Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suk Yun Kang, MD, PhD, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01855633
Other Study ID Numbers:
  • 2013-019
First Posted:
May 16, 2013
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Aug 18, 2021