UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020532
Receipt number R000023703
Scientific Title Investigation of modulation for dopaminergic neuronal system by transcranial direct current stimulation (tDCS)
Date of disclosure of the study information 2016/01/13
Last modified on 2016/01/12 15:24:59

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Basic information

Public title

Investigation of modulation for dopaminergic neuronal system by transcranial direct current stimulation (tDCS)

Acronym

Investigation of modulation for dopaminergic neuronal system by transcranial direct current stimulation (tDCS)

Scientific Title

Investigation of modulation for dopaminergic neuronal system by transcranial direct current stimulation (tDCS)

Scientific Title:Acronym

Investigation of modulation for dopaminergic neuronal system by transcranial direct current stimulation (tDCS)

Region

Japan


Condition

Condition

health male adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate changes of binding potential of [11C]raclopride, functional connectivity and cognitive function after tDCS among healthy male adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of binding potential of D2 receptor, functional connectivity and cognitive function after tDCS

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

1) After tDCS active stimulation (2mA, 15min), we investigate each examination below;
(a) brain MRI
(b) [11C] raclopride PET scan (6mCi, single injection)
(c) cognitive function test

2) After tDCS sham stimulation (2mA, 15min), we investigate each examination below;
(a) brain MRI
(b) [11C] raclopride PET scan (6mCi, single injection)
(c) cognitive function test

Interventions/Control_2


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

40 years-old >

Gender

Male

Key inclusion criteria

1) Subjects who are healthy and don't have medical history of psychiatry, neurological and other severe physical diseases

2) Subjects who have the ability to provide informed consent

3) Subjects who are between 20 and 40 years old, right-handed and non-smoker

Key exclusion criteria

1) Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.)

2) Subjects with claustrophobia

3) From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study

4) Subjects who take antihistamine drugs within one week of the study

5) Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makiko Yamada

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code


Address

4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan

TEL

81432063025

Email

myamada@nirs.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuko Suzuki

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code


Address

4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan

TEL

81432063025

Homepage URL


Email

khsuzuki@nirs.go.jp


Sponsor or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 13 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

Preinitiation

Date of protocol fixation

2015 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 02 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 12 Day

Last modified on

2016 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name