UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023038 |
|---|---|
| Receipt number | R000026553 |
| Scientific Title | Brain imaging study on the relation between emotion and cognitive function |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2018/07/09 10:00:27 |
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Basic information
Public title
Brain imaging study on the relation between emotion and cognitive function
Acronym
Brain imaging study on the relation between emotion and cognitive function
Scientific Title
Brain imaging study on the relation between emotion and cognitive function
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuomi Ouchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Oboshi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Innovative Medical Photonics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2392
Homepage URL
oboshi@hama-med.ac.jp
Sponsor or person
Institute
Preeminent Medical Photonics Education & Research Center, Hamamatsu University School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026553
