Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Brain on the Neurotransmitter Binding

June 26, 2017 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

Effect of rTMS Over Primary Motor Cortex on Gamma-aminobutyric Acid A (GABAA)-[18F]Flumazenil Binding: A Positron Emission Tomography (PET) Study

The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this study) to its receptor using the special PET study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact mechanism is not well determined in human-beings. Changes in some neurotransmitters' status in brain after rTMS have been suggested as a possible mechanism, but role of GABA is not clear.

Twelve healthy people will be recruited. They will receive the rTMS over the primary motor cortex of the dominant hand. Individual subject will receive three sessions of rTMS with wash-out period (more than 3 days) between the rTMS sessions. Three rTMS sessions are high frequency (10Hz), low frequency (1Hz) and sham rTMS. The order of rTMS sessions will be randomly decided. After completing each rTMS session, [18F]flumazenil-PET will be checked.

The purpose of this study is to investigate 1)whether rTMS over the primary motor cortex can modulate the [18F]flumazenil binding potential and 2)whether the modulation of [18F]flumazenil binding potential by rTMS can be different according to the applied frequency of rTMS.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy people
  • 18-50 yrs old
  • Right handedness
  • Written informed consent

Exclusion Criteria:

  • Previous medical diseases such as seizure, stroke, diabetes, hypertension.
  • Taking any drugs
  • Smoker
  • Pregnancy
  • Contraindication of PET or MRI
  • Stroke or any tumor in MRI
  • Metals objects in the head or eyes
  • Cardiac pacemaker or cochlear implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High frequency (10Hz) rTMS
<high frequency rTMS parameters> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 10Hz; Number of total stimuli: 750; Coil orientation: tangential to scalp
Device: High frequency rTMS
Other Names:
  • Magpro (high frequency)
EXPERIMENTAL: Low frequency (1Hz) rTMS
<low frequency rTMS parameters> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1200; Coil orientation: tangential to the scalp
Device: Low frequency rTMS
Other Names:
  • Magpro (low frequency)
SHAM_COMPARATOR: Sham rTMS
<Sham rTMS parameters> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1200; Coil orientation: perpendicular to scalp
Device: Sham rTMS
Other Names:
  • Magpro (sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[18F]flumazenil binding potential
Time Frame: up to 3 months
Immediately after rTMS session , PET image will be acquired. By using these images, [18F]flumazenil binding potential will be calculated in selected anatomical region up to 3 months
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Purdue pegboard test score
Time Frame: Before rTMS (baseline) and average 2hours after rTMS
evaluation for hand function
Before rTMS (baseline) and average 2hours after rTMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of Health & Welfare, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (ESTIMATE)

March 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1211-178-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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