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Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Traditional Theta burst stimulation (TBS)
Modified TBS rTMS
Sham rTMS
Sponsored by
Dongtan Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongtan Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Tradtional Theta burst stimulation (TBS) rTMS

Modified TBS rTMS

Sham rTMS

Arm Description

Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)

Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)

Participants will receive sham cTBS rTMS to contralesional hemisphere.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2013
Last Updated
September 6, 2023
Sponsor
Dongtan Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01855633
Brief Title
Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
Official Title
Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2039 (Anticipated)
Study Completion Date
December 2040 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongtan Sacred Heart Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tradtional Theta burst stimulation (TBS) rTMS
Arm Type
Experimental
Arm Description
Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)
Arm Title
Modified TBS rTMS
Arm Type
Active Comparator
Arm Description
Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Participants will receive sham cTBS rTMS to contralesional hemisphere.
Intervention Type
Device
Intervention Name(s)
Traditional Theta burst stimulation (TBS)
Intervention Type
Device
Intervention Name(s)
Modified TBS rTMS
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Primary Outcome Measure Information:
Title
Keyboard tapping test
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suk Yun Kang, MD, PhD
Phone
82-31-8086-2310
Email
sukyunkang@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ah-Young Jun, MD, MS
Phone
82-31-8086-2310
Email
ayjun@hallym.or.kr
Facility Information:
Facility Name
Dongtan Sacred Heart Hospital
City
Hwaseong Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
445-170
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk Yun Kang, MD, PhD
Phone
82-31-8086-2310
Email
sukyunkang@hanmail.net
First Name & Middle Initial & Last Name & Degree
Ah-Young Jun, MD, MS
Phone
82-31-8086-2310
Email
ayjun@hallym.or.kr
First Name & Middle Initial & Last Name & Degree
Suk Yun Kang, MD, PhD

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

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