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

Primary Purpose

Stroke, Hemiplegia

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low frequency rTMS
High frequency rTMS
Sham rTMS
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Neuronal plasticity, Neurotransmitter agents, Receptors, neurotransmitter, Transcranial magnetic stimulation, Stroke, gamma-Aminobutyric Acid

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

High frequency (10Hz) rTMS

Low frequency (1Hz) rTMS

Sham rTMS

Arm Description

<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

<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

<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

Outcomes

Primary Outcome Measures

[18F]flumazenil binding potential
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

Secondary Outcome Measures

Purdue pegboard test score
evaluation for hand function

Full Information

First Posted
March 19, 2013
Last Updated
June 26, 2017
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01819675
Brief Title
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Brain on the Neurotransmitter Binding
Official Title
Effect of rTMS Over Primary Motor Cortex on Gamma-aminobutyric Acid A (GABAA)-[18F]Flumazenil Binding: A Positron Emission Tomography (PET) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
exposure to radiation due to repetitive PET evaluation
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Neuronal plasticity, Neurotransmitter agents, Receptors, neurotransmitter, Transcranial magnetic stimulation, Stroke, gamma-Aminobutyric Acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High frequency (10Hz) rTMS
Arm Type
Experimental
Arm Description
<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
Arm Title
Low frequency (1Hz) rTMS
Arm Type
Experimental
Arm Description
<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
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
<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
Intervention Type
Device
Intervention Name(s)
Low frequency rTMS
Other Intervention Name(s)
Magpro (low frequency)
Intervention Type
Device
Intervention Name(s)
High frequency rTMS
Other Intervention Name(s)
Magpro (high frequency)
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Magpro (sham)
Primary Outcome Measure Information:
Title
[18F]flumazenil binding potential
Description
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
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Purdue pegboard test score
Description
evaluation for hand function
Time Frame
Before rTMS (baseline) and average 2hours after rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23002939
Citation
Ayache SS, Farhat WH, Zouari HG, Hosseini H, Mylius V, Lefaucheur JP. Stroke rehabilitation using noninvasive cortical stimulation: motor deficit. Expert Rev Neurother. 2012 Aug;12(8):949-72. doi: 10.1586/ern.12.83.
Results Reference
background
PubMed Identifier
15450156
Citation
Malenka RC, Bear MF. LTP and LTD: an embarrassment of riches. Neuron. 2004 Sep 30;44(1):5-21. doi: 10.1016/j.neuron.2004.09.012.
Results Reference
background
PubMed Identifier
17562028
Citation
Thickbroom GW. Transcranial magnetic stimulation and synaptic plasticity: experimental framework and human models. Exp Brain Res. 2007 Jul;180(4):583-93. doi: 10.1007/s00221-007-0991-3. Epub 2007 Jun 12.
Results Reference
background
PubMed Identifier
19401169
Citation
Yue L, Xiao-lin H, Tao S. The effects of chronic repetitive transcranial magnetic stimulation on glutamate and gamma-aminobutyric acid in rat brain. Brain Res. 2009 Mar 13;1260:94-9. doi: 10.1016/j.brainres.2009.01.009. Epub 2009 Jan 12.
Results Reference
background
PubMed Identifier
19701632
Citation
Trippe J, Mix A, Aydin-Abidin S, Funke K, Benali A. theta burst and conventional low-frequency rTMS differentially affect GABAergic neurotransmission in the rat cortex. Exp Brain Res. 2009 Dec;199(3-4):411-21. doi: 10.1007/s00221-009-1961-8.
Results Reference
background

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

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