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

NCT ID: NCT01819675

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

High frequency rTMS

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Low frequency rTMS

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

Interventions

Low frequency rTMS

Intervention Type: DEVICE

High frequency rTMS

Intervention Type: DEVICE

Sham rTMS

Intervention Type: DEVICE

Other Intervention Names

Magpro (low frequency); Magpro (high frequency); Magpro (sham)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nam-Jong Paik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nam-Jong Paik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 23002939 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15450156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17562028 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19401169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19701632 (View on PubMed)

Other Identifiers

E-1211-178-001

Identifier Type: -

Identifier Source: org_study_id