UMIN-CTR Clinical Trial

Basic information
Public title	Effect of restraint-free PET on stress responses and brain activities
Acronym	Restraint-free PET and brain function
Scientific Title	Effect of restraint-free PET on stress responses and brain activities
Scientific Title:Acronym	Restraint-free PET and brain function
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effect of restraint-free PET on stress responses and brain activation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Head restraint-induced changes of PET data
Key secondary outcomes	1. Physiological stress responses 2. Psychological stress responses 3. Performances in cognitive tasks 4. Correlation between stress responses and PET data 5. Differences among stress responses before, durnig, and after PET scannings 6. Correlation between head movements and PET data

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	Device,equipment
Interventions/Control_1	Measurements of [15O]H2O-PET and [11C]Raclopride-PET during with/without head restraint. Measurements of physiological and psychological stress responses before, during and after PET scan.
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	1. Individuals without a neurological or psychiatric history 2. Aged 20 to 60 years 3. Right-handed 4. Male 5. Capability of informed consent based on their own decision
Key exclusion criteria	1.People with a history of traumatic brain injury and a episode of an unconsciousness lasting more than 5 minutes 2.People with a history of organic brain diseases 3. Individuals with a history or current history of substance dependence 4. Individuals who are taking central nervous system stimulants 5. Individuals who have a history of disorders of consciousness and/or seizure 6. Individuals who have a chronic headache 7. Individuals who are unable to undergo MRI
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroyuki okada
Organization	Hamamatsu Photonics K.K.
Division name	Buisiness Accerelater, Global Strategic Challenge Center
Zip code
Address	5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL	053-584-0200
Email	hiroyuki.okada@hpk.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Tomoo Inubushi
Organization	Hamamatsu Photonics K.K.
Division name	PET Medical Application Group, Central Research Laboratory
Zip code
Address	5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL	053-584-0728
Homepage URL
Email	tomoo.inubushi@crl.hpk.co.jp

Sponsor
Institute	Hamamatsu Photonics K.K.
Institute
Department

Funding Source
Organization	Hamamatsu Photonics K.K.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hamamatsu Medical Photonics Foundation.
Name of secondary funder(s)	None

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 11 Month 27 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 03 Month 31 Day
Date of IRB	2015 Year 10 Month 19 Day
Anticipated trial start date	2017 Year 05 Month 10 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 26 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039486