UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023774
Receipt number R000027391
Scientific Title Developing an index (BETs) for quantitatively evaluating brain activation
Date of disclosure of the study information 2016/08/26
Last modified on 2019/02/26 10:12:49

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Basic information

Public title

Developing an index (BETs) for quantitatively evaluating brain activation

Acronym

Quantitative evaluation method for brain activation

Scientific Title

Developing an index (BETs) for quantitatively evaluating brain activation

Scientific Title:Acronym

Quantitative evaluation method for brain activation

Region

Japan


Condition

Condition

brain activation

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our purpose is to develop an index for quantitatively evaluating degree of brain activation measured by NIRS (Near-infrared spectroscopy)

Basic objectives2

Others

Basic objectives -Others

Because brain activation measured by NIRS is relative amount, we cannot simply evaluate degree of brain activation between subjects. Therefore, we try to develop an index for quantitatively evaluating degree of brain activation measured by NIRS.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Task difficulty (VAS)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

NA
right handed

Key exclusion criteria

psychiatric disorder
left handed
poor eyesight

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

Institute of Development, Aging and Cancer,
Tohoku University (IDAC)

Division name

Smart Aging International Research Center

Zip code


Address

Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN

TEL

022-717-7988

Email

fbi@grp.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeyuki Ikeda

Organization

Institute of Development, Aging and Cancer, Tohoku University (IDAC)

Division name

Ubiquitous Sensing

Zip code


Address

Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN

TEL

022-717-7988

Homepage URL


Email

fbi@grp.tohoku.ac.jp


Sponsor or person

Institute

Institute of Development, Aging and Cancer,
Tohoku University (IDAC)

Institute

Department

Personal name



Funding Source

Organization

Japanese business 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

2016 Year 08 Month 26 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

Completed

Date of protocol fixation

2016 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2016 Year 08 Month 26 Day

Last modified on

2019 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027391


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name