UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020566 |
|---|---|
| Receipt number | R000023746 |
| Scientific Title | Examination of dopaminergic system using neurofeedback technique |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/10/31 11:26:28 |
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Basic information
Public title
Examination of dopaminergic system using neurofeedback technique
Acronym
Examination of dopaminergic system using neurofeedback technique
Scientific Title
Examination of dopaminergic system using neurofeedback technique
Scientific Title:Acronym
Examination of dopaminergic system using neurofeedback technique
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the correlation between the neural modulation by neurofeedback training and the intensity of dopamine receptors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between the change of BOLD signals, the psychological changes and the intensity of dopamine receptor
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
| Behavior,custom |
Interventions/Control_1
(1) Psychophysiological measurements
Day1: 60 min in twice
Day3: 60 min in twice
(2) Structural MRI
Day1: 20 min
Day3: 20 min
(3) Functional MRI
Day1: 120 min
Day3: 120 min
(4) PET scan
Day2: [11C] raclopride (6mCi, single injection)
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
Healthy individuals who have the ability to provide informed consent.
Key exclusion criteria
Psychiatric disorders including drug dependence
Serious medical illness
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
043-206-3251
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
043-206-3025
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
Other
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 | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 14 | 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 | 14 | Day |
Last modified on
| 2016 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023746
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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