UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022286 |
|---|---|
| Receipt number | R000025663 |
| Scientific Title | Investigating neurotransmitters by high-sensitivity proton MRS |
| Date of disclosure of the study information | 2016/05/13 |
| Last modified on | 2021/12/08 15:43:03 |
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Basic information
Public title
Investigating neurotransmitters by high-sensitivity proton MRS
Acronym
Investigating neurotransmitters by high-sensitivity proton MRS
Scientific Title
Investigating neurotransmitters by high-sensitivity proton MRS
Scientific Title:Acronym
Investigating neurotransmitters by high-sensitivity proton MRS
Region
| Japan |
Condition
Condition
brain diseases
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the usefullness of MR sequences (SPECIAL and MEGA-PRESS) for evaluating neurotransmitters with healthy volunteers.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A) Optimization of imaging parameters
B) evaluation of the sensitivity for measuring neurotransmitters by SPECIAL and MEGA-PRESS
Key secondary outcomes
1. Gender difference of brain metabolites
2. Regional distribution of brain metabolites
3. Association between brain and plasma metabolites
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
right handed
Key exclusion criteria
1. Persons who have brain diseases
2. Substance dependence
3. Persons who have serious complications or persons who had serious complications before which are not appropriate for this study based on the judgement of the researcher/doctor.
4. Persons who have a pacemaker or any metal in his body
5. Persons who have a tatoo
6. Persons who have serious claustrophobia
7. Pregnancy
8. Other persons who are determined by the researcher/doctor.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhei Takado |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3425
takado.yuhei@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuhei Takado |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3425
Homepage URL
takado.yuhei@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science & Technology in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
The sensitivity of the measurement of each pulse sequence will be observed.
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
