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
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
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
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
