UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000020583
Receipt number	R000023446
Scientific Title	Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects
Date of disclosure of the study information	2016/03/01
Last modified on	2018/06/18 16:00:40

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Basic information

Public title

Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects

Acronym

Effect of tDCS on the dopamine-GABA systems in healthy subjects

Scientific Title

Effect of transcranial direct current stimulation on the dopamine-GABA systems in healthy subjects

Scientific Title:Acronym

Effect of tDCS on the dopamine-GABA systems in healthy subjects

Region

Japan

Condition

psychiatric and neurological disease

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

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

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name ouchi yasuomi

Organization

Hamamatsu University School of Medicine

Division name

Department of Biofunctional Imaging

Zip code

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

1st name

Middle name

Last name bunai tomoyasu

Organization

Hamamatsu University School of Medicine

Division name

Department of Biofunctional Imaging

Zip code

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 or person

Institute

Department of Biofunctional Imaging, Hamamatsu University School of Medicine

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 01 Month 15 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023446

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name