UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038436
Receipt number R000043797
Scientific Title A study of brain activity during simulated driving and corresponding cognitive functions.
Date of disclosure of the study information 2019/11/15
Last modified on 2023/05/08 11:26:51

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Basic information

Public title

A study of brain activity during simulated driving and corresponding cognitive functions.

Acronym

A study of brain activity during simulated driving and corresponding cognitive functions.

Scientific Title

A study of brain activity during simulated driving and corresponding cognitive functions.

Scientific Title:Acronym

A study of brain activity during simulated driving and corresponding cognitive functions.

Region

Japan


Condition

Condition

Healthy individuals/Mild cognitive impairment

Classification by specialty

Neurology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A study of brain activity during simulated driving and corresponding cognitive functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The correlation between the change of BOLD signals, the driving manipulation and the cognitive functions.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

1) Ordinary drivers
Day1
Screening test: 10min
Break time
Cognitive test: 90min
Break time
Psychological test:80min

Day2
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min

Interventions/Control_2

2) Old drivers
Day1
Screening test: 10min
Break time
Cognitive test: 90min
Break time
Psychological test:80min

Day2
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min

Interventions/Control_3

3) Risk minimum drivers
Day1
Screening test: 10min

Day2
Cognitive test: 90min
Break time
Psychological test:80min

Day3
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min

Interventions/Control_4

4) Drivers with mild cognitive impairment
Day1
Screening test: 10min
Break time
Cognitive test: 90min
Break time
Psychological test:80min

Day2
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy individuals who have the ability to provide informed consent.

Key exclusion criteria

Psychiatric disorders including drug dependence
Serious medical illness

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Makiko
Middle name
Last name Yamada

Organization

National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
Institute for Quantum Medical Science

Division name

Department of Functional Brain Imaging Research

Zip code

263-8555

Address

4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan

TEL

043-206-3251

Email

yamada.makiko@qst.go.jp


Public contact

Name of contact person

1st name Yasunori
Middle name
Last name Aizawa

Organization

National Institutes for Quantum Science and Technology Institute for Quantum Medical Science

Division name

Department of Functional Brain Imaging Research

Zip code

263-8555

Address

4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan

TEL

043-206-3025

Homepage URL


Email

aizawa.yasunori@qst.go.jp


Sponsor or person

Institute

National Institutes for Quantum Science and Technology

Institute

Department

Personal name



Funding Source

Organization

Honda R&D Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Certified Review Board

Address

4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba

Tel

043-206-4709

Email

helsinki@qst.go.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

2019 Year 11 Month 15 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

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 29 Day

Date of IRB

2019 Year 10 Month 29 Day

Anticipated trial start date

2019 Year 11 Month 20 Day

Last follow-up date

2024 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

2019 Year 10 Month 30 Day

Last modified on

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043797


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name