UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects
Title of the study (Brief title)	Effect of tDCS on the dopamine-GABA systems in healthy subjects
Region	Japan

Condition
Condition	psychiatric and neurological disease
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effect of transcranial direct current stimulation(tDCS) on the dopamine-GABA systems, using raclopride PET and Magnetic Resonance Spectroscopy(MRS).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Analyze changes in binding potential of [11C]raclopride in PET and GABA levels in MRS between tDCS and sham stimulation conditions.
Key secondary outcomes	Analyze changes of cognitive test scores between tDCS and sham stimulation conditions.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Anodal and cathodal electrodes are placed at the left frontal areas and right frontal areas, respectively. 13-min tDCS with a current intensity of 2 mA is applied twice with a 20-min. After more than a month, sham stimulation is applied. With the same electrodes placed as in the true stimulation condition, sham stimulation is switched off 30 seconds after stimulation start. After each stimulation, raclopride PET and MRS is performed.
Interventions/Control_2	First, sham stimulation is applied. After more than a month, true stimulation is applied. After each stimulation, raclopride PET and MRS is performed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1.Healthy right-handed man over twenty years of age 2.With intelligence score IQ>80 on the Japanese Adult Reading Test 3.People who have consent to participate in this research
Key exclusion criteria	1.People with a history of traumatic brain injury and a episode of an unconsciousness lasting more than 5 minutes 2.People with a history of organic brain diseases 3.People with a history of seizure 4.People with chronic headache 5.People who cannot undergo an MRI scan
Target sample size	22

Research contact person
Name of lead principal investigator	ouchi yasuomi
Organization	Hamamatsu University School of Medicine
Division name	Department of Biofunctional Imaging
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2466
Email	ouchi@hama-med.ac.jp

Public contact
Name of contact person	bunai tomoyasu
Organization	Hamamatsu University School of Medicine
Division name	Department of Biofunctional Imaging
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2466
Homepage URL
Email	bunai.t@hama-med.ac.jp

Sponsor
Institute	Department of Biofunctional Imaging, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Scholarship donations
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanazawa University
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松PET診断センター、浜松ホトニクス（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 15 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023446