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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01877161
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : June 4, 2014
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.

Condition or disease Intervention/treatment
To Healthy Volunteer Virtual Lesions for Aphasia Device: Repetitive magnetic stimulation to superior temporal gyrus Device: Repetitive magnetic stimulation to middle temporal gyrus Device: Repetitive magnetic stimulation (Sham)

Detailed Description:
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
Study Start Date : December 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Middle temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrus
Device: Repetitive magnetic stimulation to middle temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrus
Other Name: MagPro X100 magnetic stimulator
Sham Comparator: Control group
Repetitive magnetic stimulation (Sham)
Device: Repetitive magnetic stimulation (Sham)
Repetitive magnetic stimulation (Sham)
Other Name: MagPro X100 magnetic stimulator
Experimental: Superior temporal gyrus
Repetitive magnetic stimulation to superior temporal gyrus
Device: Repetitive magnetic stimulation to superior temporal gyrus
Repetitive magnetic stimulation to superior temporal gyrus
Other Name: MagPro X100 magnetic stimulator


Outcome Measures

Primary Outcome Measures :
  1. The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) [ Time Frame: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3) ]

    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



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877161


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Seoul National University Bundang Hospital
More Information

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01877161     History of Changes
Other Study ID Numbers: E-1206-158-003
First Posted: June 13, 2013    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: July 31, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms