UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of attention on the neural correlates of ambient thermal sensation
Title of the study (Brief title)	Neural correlates of ambient thermal sensation
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the effect of attention on the neural correlates of ambient thermal sensation using fMRI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain activity correlating thermal sensation under the attention task
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	Prevention
Type of intervention	Other
Interventions/Control_1	functional 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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy undergraduate and graduate students
Key exclusion criteria	(1) people who have ferromagnetic items inside and surface of the body (such as pacemeker, aneurysm clip and tattoo), who are claustrophobic, and who are in pregnancy. (2) people who have past and present medical history of psychiatric and neurological disorders (3) people who are left-handedness (4) people who are claustrophobia (5) people during pregnancy (6) people who weigh more than 65 kg
Target sample size	40

Research contact person
Name of lead principal investigator	Motoaki Sugiura
Organization	Tohoku University
Division name	Department of Human Brain Science, Institute of Development, Aging and Cancer
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8563
Email	sugiura@tohoku.ac.jp

Public contact
Name of contact person	Kentaro Oba
Organization	Tohoku University
Division name	Department of Human Brain Science, Institute of Development, Aging and Cancer
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8563
Homepage URL
Email	kentaro.oba.c6@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Nissan Motor Co., Ltd.
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	2017 Year 10 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 01 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

Management information
Registered date	2017 Year 10 Month 17 Day
Last modified on	2017 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033805