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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Ministry for Health, Welfare and Family Affairs, 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: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Stroke
Hemiplegia
Device: Low frequency rTMS
Device: High frequency rTMS
Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • [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


Secondary Outcome Measures:
  • Purdue pegboard test score [ Time Frame: Before rTMS (baseline) and average 2hours after rTMS ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: High frequency rTMS
Other Name: Magpro (high frequency)
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
Device: Low frequency rTMS
Other Name: Magpro (low frequency)
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
Device: Sham rTMS
Other Name: Magpro (sham)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819675

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Ministry for Health, Welfare and Family Affairs, Korea
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  More Information

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
Study First Received: March 19, 2013
Last Updated: May 13, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:
Neuronal plasticity
Neurotransmitter agents
Receptors, neurotransmitter
Transcranial magnetic stimulation
Stroke
gamma-Aminobutyric Acid

Additional relevant MeSH terms:
Hemiplegia
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Gamma-Aminobutyric Acid
Neurotransmitter Agents
GABA Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014