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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01819675
• Other study ID #: E-1211-178-001
• Status: Terminated
• Phase: N/A
• First received: March 19, 2013
• Last updated: June 26, 2017
• Start date: March 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Low frequency rTMS

• High frequency rTMS

• Sham rTMS

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

Trippe J, Mix A, Aydin-Abidin S, Funke K, Benali A. ? 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. — View 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. Epub 2009 Jan 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	up to 3 months
Secondary	Purdue pegboard test score	evaluation for hand function	Before rTMS (baseline) and average 2hours after rTMS