UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023889
Receipt number R000027519
Scientific Title An MEG study regarding the neural effects of fatigue sensation on performance
Date of disclosure of the study information 2017/01/01
Last modified on 2020/03/04 09:19:59

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Basic information

Public title

An MEG study regarding the neural effects of fatigue sensation on performance

Acronym

An MEG study regarding the neural effects of fatigue sensation on performance

Scientific Title

An MEG study regarding the neural effects of fatigue sensation on performance

Scientific Title:Acronym

An MEG study regarding the neural effects of fatigue sensation on performance

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the neural effects of fatigue sensation on performance in fatigue

Basic objectives2

Others

Basic objectives -Others

To investigate the neural mechanisms of fatigue

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The MEG data

Key secondary outcomes

Questionnaires, grip strength


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Cognitive task 1, cognitive task 2

Interventions/Control_2

Cognitive task 2, cognitive task 1

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult

Key exclusion criteria

Participants with past or current history of serious medical illness and/or brain organic disease, who take central nerve system acting drugs, who are contradicted for the use of MRI, and who are judged as not suitable for participation in this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaaki Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Physiology

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585

TEL

06-6645-3711

Email

m5914885@msic.med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Ishii

Organization

Osaka City University Graduate School of Medicine

Division name

Physiology

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585

TEL

06-6645-3711

Homepage URL


Email

a.ishii@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

大阪市立大学医学部附属病院(大阪), Osaka City University Hospital (Osaka)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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

Terminated

Date of protocol fixation

2016 Year 08 Month 30 Day

Date of IRB

2016 Year 08 Month 30 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2020 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

2016 Year 09 Month 01 Day

Last modified on

2020 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name