UMIN-CTR Clinical Trial

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
Email	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
Email	takado.yuhei@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025663