UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Developing an index (BETs) for quantitatively evaluating brain activation
Title of the study (Brief title)	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	Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer, Tohoku University (IDAC)
Division name	Smart Aging International Research Center
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	Shigeyuki Ikeda
Organization	Institute of Development, Aging and Cancer, Tohoku University (IDAC)
Division name	Ubiquitous Sensing
Address	Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN
TEL	022-717-7988
Homepage URL
Email	fbi@grp.tohoku.ac.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027391