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

Not Applicable

Terminated

• Conditions: Stroke; Hemiplegia
• Interventions: Device: Sham rTMS; Device: Low frequency rTMS; Device: High frequency rTMS

• Registration Number: NCT01819675
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Healthy people
• 18-50 yrs old
• Right handedness
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham rTMS	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
Low frequency (1Hz) rTMS	Low frequency 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
High frequency (10Hz) rTMS	High frequency 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

Primary Outcome Measures

Name	Time	Method
[18F]flumazenil binding potential	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

Secondary Outcome Measures

Name	Time	Method
Purdue pegboard test score	Before rTMS (baseline) and average 2hours after rTMS	evaluation for hand function

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of