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

This study has suspended participant recruitment.
(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: November 17, 2014
Last verified: November 2014

March 19, 2013
November 17, 2014
March 2013
December 2015   (final data collection date for primary outcome measure)
[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
Same as current
Complete list of historical versions of study NCT01819675 on ClinicalTrials.gov Archive Site
Purdue pegboard test score [ Time Frame: Before rTMS (baseline) and average 2hours after rTMS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Brain on the Neurotransmitter Binding
Effect of rTMS Over Primary Motor Cortex on Gamma-aminobutyric Acid A (GABAA)-[18F]Flumazenil Binding: A Positron Emission Tomography (PET) Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
  • Stroke
  • Hemiplegia
  • Device: Low frequency rTMS
    Other Name: Magpro (low frequency)
  • Device: High frequency rTMS
    Other Name: Magpro (high frequency)
  • Device: Sham rTMS
    Other Name: Magpro (sham)
  • 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
    Intervention: Device: High frequency rTMS
  • 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
    Intervention: Device: Low frequency rTMS
  • 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
    Intervention: Device: Sham rTMS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
12
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01819675
E-1211-178-001
No
Nam-Jong Paik, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Ministry of Health & Welfare, Korea
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Seoul National University Bundang Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP