UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brain imaging study on the relation between emotion and cognitive function
Title of the study (Brief title)	Brain imaging study on the relation between emotion and cognitive function
Region	Japan

Condition
Condition	Dementia Mild cognitive impairment
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the relation between emotion and cognitive function by measuring the emotional tasks-induced brain activations using functional Magnetic Resonance Imaging (fMRI) and near-infrared spectroscopy (NIRS), and the levels of brain chemistry at the resting state using Magnetic Resonance Spectroscopy (MRS), in which we analyze the correlation between the brain imaging data and neuropsychological test scores, and compare these results between young and old subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Brain activations (BOLD signal changes, hemoglobin concentration changes) and brain chemistry concentrations, such as GABA and Glx levels
Key secondary outcomes	Correlations between neuroimaging data (BOLD signal changes, hemoglobin concentration changes and brain chemical substances) and neuropsychological test scores

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	Prevention
Type of intervention	Other
Interventions/Control_1	fMRI and NIRS measurements during the emotional task, MRS measurements during the resting state, and neuropsychological 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy participants aged 20 to 29 years (young), aged 65 to 74 years (elderly) 2. Individuals who have no history of psychiatric disease 3. Individuals who are right-handed 4. Individuals who are consent to participate in this study 5. Critetria for elderly subject: 1) Individuals with Mini-mental state examination scores over 26 at screening, 2) Individuals with Clinical dementia rating scale score 0, 3) Individuals whose ADL is normal without any memory problems
Key exclusion criteria	1. Individuals who have a history of traumatic brain injury with an unconsciousness lasting more than 5 minutes 2. Individuals who have a history of organic brain disease 3. Individuals who have a history of psychiatric disease 4. Individuals who have a history of substance dependence 5. Individuals who are taking central nervous system stimulants 6. Individuals who have a history of disorders of consciousness and/or seizure 7. Individuals who have a chronic headache 8. Individuals who have a risk for MRI scan 9. Criteria for elderly subject: 1) Individuals who have one or multiple following diagnosis: dementia (AD, FTLD, DLB), MCI, brain damage (cerebral infarction, brain hemorrhage, head trauma), Parkinsonism, Parkinson syndrome, corticobasal degeneration, 2) Individuals who have one or multiple following symptoms or disease: hearing difficulty, impaired vision, finger tremor, disease of cervical spine, cervical injury, neck pain
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuomi Ouchi
Organization	Hamamatsu University School of Medicine
Division name	Department of Biofunctional Imaging
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2466
Email	ouchi@hama-med.ac.jp

Public contact
Name of contact person	Yumi Oboshi
Organization	Hamamatsu University School of Medicine
Division name	Department of Innovative Medical Photonics
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2392
Homepage URL
Email	oboshi@hama-med.ac.jp

Sponsor
Institute	Preeminent Medical Photonics Education & Research Center, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hamamatsu Medical Photonics Foundation
Name of secondary funｄer(s)

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	浜松PET診断センター（静岡県）、浜松医科大学

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2018 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026553