UMIN-CTR Clinical Trial

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

Dementia
Mild cognitive impairment

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

ouchi@hama-med.ac.jp

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

Email

oboshi@hama-med.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Hamamatsu Medical Photonics Foundation

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松PET診断センター（静岡県）、浜松医科大学

Date of disclosure of the study information

2016

Year

07

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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