Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Brain on the Neurotransmitter Binding
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ClinicalTrials.gov Identifier: NCT01819675 |
Recruitment Status
:
Terminated
(exposure to radiation due to repetitive PET evaluation)
First Posted
: March 27, 2013
Last Update Posted
: June 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Hemiplegia | Device: Low frequency rTMS Device: High frequency rTMS Device: Sham rTMS | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | February 2016 |
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
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Device: High frequency rTMS
Other Name: Magpro (high frequency)
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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
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Device: Low frequency rTMS
Other Name: Magpro (low frequency)
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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
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Device: Sham rTMS
Other Name: Magpro (sham)
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- [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
- Purdue pegboard test score [ Time Frame: Before rTMS (baseline) and average 2hours after rTMS ]evaluation for hand function

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819675
Korea, Republic of | |
Seoul National University Bundang Hospital | |
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 |
Principal Investigator: | Nam-Jong Paik, MD, PhD | Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea |
Publications:
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 |
First Posted: | March 27, 2013 Key Record Dates |
Last Update Posted: | June 27, 2017 |
Last Verified: | June 2017 |
Keywords provided by Nam-Jong Paik, 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 |