UMIN-CTR Clinical Trial

Basic information
Public title	A cognitive neuroimaging study using MRI: establishment of a measurement protocol for healthy controls
Acronym	A cognitive neuroimaging study using MRI
Scientific Title	A cognitive neuroimaging study using MRI: establishment of a measurement protocol for healthy controls
Scientific Title:Acronym	A cognitive neuroimaging study using MRI
Region	Japan

Condition
Condition	healthy control
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(1) Establishment of a cognitive neuroimaging protocol using MRI, (2) Basic scientific research by healthy controls
Basic objectives2	Others
Basic objectives -Others	(1) We establish a measurement protocol for a cognitive neuroimaging study using MRI in our site. (2) We combine MRI measurements with cognitive neuropsychological tests/behavioral tests to examine the relationships between imaging data and the test scores including those for hand preferences and various cognitive performances.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MRI (fMRI, diffusion imaging, structural images), hand preference scores, reaction time, developmental disorder inventory scores, mental health indices, working memory scores
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	MRI scans
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy subjects with no psychoneurological disorders aged 18 or over
Key exclusion criteria	people who are not to undergo MRI
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kayako Middle name Last name Matsuo
Organization	Dokkyo Medical University
Division name	Center for Research Collaboration and Support
Zip code	321-0293
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111(5692)
Email	kayako@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Kayako Middle name Last name Matsuo
Organization	Dokkyo Medical University
Division name	Center for Research Collaboration and Support
Zip code	321-0293
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111(5692)
Homepage URL
Email	kayako@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University, Center for Research Collaboration and Support
Institute
Department

Funding Source
Organization	Dokkyo Medical University
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	Dokkyo Medical University, Research Support Section
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel	0282-86-1111
Email	kenkyu@dokkyomed.ac.jp

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	2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	83
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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 01 Day
Date of IRB	2016 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 09 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035651