UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020532
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute National Institute of Radiological Sciences
Institute
Department

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
URL(English) https://upload.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


Contact us.