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

This study has been terminated.

(After doing some preliminary analysis, investigators will decide whether to go or stop.)

Sponsor:

Collaborator:

Ministry of Health & Welfare, Korea

Information provided by (Responsible Party):

Nam-Jong Paik, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT01819675

First received: March 19, 2013

Last updated: February 26, 2016

Last verified: February 2016

History of Changes

Purpose

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.

Condition	Intervention
Stroke Hemiplegia	Device: Low frequency rTMS Device: High frequency rTMS Device: Sham rTMS


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effect of rTMS Over Primary Motor Cortex on Gamma-aminobutyric Acid A (GABAA)-[18F]Flumazenil Binding: A Positron Emission Tomography (PET) Study

Resource links provided by NLM:

Drug Information available for: Gamma-aminobutyric acid

Genetic and Rare Diseases Information Center resources: Hemiplegia

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:

[18F]flumazenil binding potential [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Before rTMS (baseline) and average 2hours after rTMS ] [ Designated as safety issue: No ]


Estimated Enrollment:	12
Study Start Date:	March 2013
Study Completion Date:	February 2016
Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Magpro (sham)

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819675

Locations


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

Sponsors and Collaborators

Seoul National University Bundang Hospital

Ministry of Health & Welfare, Korea

Investigators


Principal Investigator:	Nam-Jong Paik, MD, PhD	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

More Information

Publications:

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. Review.

Malenka RC, Bear MF. LTP and LTD: an embarrassment of riches. Neuron. 2004 Sep 30;44(1):5-21. Review.

Thickbroom GW. Transcranial magnetic stimulation and synaptic plasticity: experimental framework and human models. Exp Brain Res. 2007 Jul;180(4):583-93. Epub 2007 Jun 12. Review.

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. Epub 2009 Jan 12.

Trippe J, Mix A, Aydin-Abidin S, Funke K, Benali A. θ 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.


Responsible Party:	Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:	NCT01819675 History of Changes
Other Study ID Numbers:	E-1211-178-001
Study First Received:	March 19, 2013
Last Updated:	February 26, 2016
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:


Neuronal plasticity Neurotransmitter agents Receptors, neurotransmitter	Transcranial magnetic stimulation Stroke gamma-Aminobutyric Acid

Additional relevant MeSH terms:


Hemiplegia Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms	Neurotransmitter Agents Gamma-Aminobutyric Acid Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs GABA Agents

ClinicalTrials.gov processed this record on September 23, 2016

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