UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034526
Receipt number R000039367
Scientific Title Neural mechanism of attention during driving
Date of disclosure of the study information 2018/10/17
Last modified on 2018/10/16 16:22:08

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Basic information

Public title

Neural mechanism of attention during driving

Acronym

Neural mechanism of attention during driving

Scientific Title

Neural mechanism of attention during driving

Scientific Title:Acronym

Neural mechanism of attention during driving

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the neural mechanisms of attention during operating driving simulator

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

brain activity during operating driving simulator

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

Other

Interventions/Control_1

MRI

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy right handed

Key exclusion criteria

metal in the body

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motoaki Sugiura

Organization

Tohoku University

Division name

Institute of Development, Aging and Cancer

Zip code


Address

Seiryo-machi 4-1, Aoba, Sendai

TEL

022-717-8563

Email

motoaki.sugiura.d6@tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Oba

Organization

Tohoku University

Division name

Institute of Development, Aging and Cancer

Zip code


Address

Seiryo-machi 4-1, Aoba, Sendai

TEL

022-717-8563

Homepage URL


Email

kentaro.oba.c6@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

DENSO Corporation

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


Address


Tel


Email



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 10 Month 17 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

Preinitiation

Date of protocol fixation

2018 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 22 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

2018 Year 10 Month 16 Day

Last modified on

2018 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name