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Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types

Primary Purpose

To Healthy Volunteer, Virtual Lesions for Aphasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Repetitive magnetic stimulation to superior temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrus
Repetitive magnetic stimulation (Sham)
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Healthy Volunteer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • fluent in Korean
  • older than 18 years old

Exclusion Criteria:

  • younger than 18 years old
  • psychotic or psychiatric problems
  • pregnant
  • contraindications to MRI/fMRI
  • uncooperative
  • metalic implants, pacemaker or cochlear implants
  • cannot perform outcome measure-related task
  • known seizure history

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

Middle temporal gyrus

Control group

Superior temporal gyrus

Arm Description

Repetitive magnetic stimulation to middle temporal gyrus

Repetitive magnetic stimulation (Sham)

Repetitive magnetic stimulation to superior temporal gyrus

Outcomes

Primary Outcome Measures

The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)
Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus). Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus. The "reaction time post TMS - reaction time pre TMS" were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG

Secondary Outcome Measures

Full Information

First Posted
March 11, 2013
Last Updated
June 26, 2017
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01877161
Brief Title
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
Official Title
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. Study Description

Brief Summary
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
Detailed Description
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Healthy Volunteer, Virtual Lesions for Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Middle temporal gyrus
Arm Type
Experimental
Arm Description
Repetitive magnetic stimulation to middle temporal gyrus
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Repetitive magnetic stimulation (Sham)
Arm Title
Superior temporal gyrus
Arm Type
Experimental
Arm Description
Repetitive magnetic stimulation to superior temporal gyrus
Intervention Type
Device
Intervention Name(s)
Repetitive magnetic stimulation to superior temporal gyrus
Other Intervention Name(s)
MagPro X100 magnetic stimulator
Intervention Description
Repetitive magnetic stimulation to superior temporal gyrus
Intervention Type
Device
Intervention Name(s)
Repetitive magnetic stimulation to middle temporal gyrus
Other Intervention Name(s)
MagPro X100 magnetic stimulator
Intervention Description
Repetitive magnetic stimulation to middle temporal gyrus
Intervention Type
Device
Intervention Name(s)
Repetitive magnetic stimulation (Sham)
Other Intervention Name(s)
MagPro X100 magnetic stimulator
Intervention Description
Repetitive magnetic stimulation (Sham)
Primary Outcome Measure Information:
Title
The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)
Description
Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus). Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus. The "reaction time post TMS - reaction time pre TMS" were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG
Time Frame
change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: fluent in Korean older than 18 years old Exclusion Criteria: younger than 18 years old psychotic or psychiatric problems pregnant contraindications to MRI/fMRI uncooperative metalic implants, pacemaker or cochlear implants cannot perform outcome measure-related task known seizure history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Bundang-gu
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types

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