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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034993
Receipt No. R000039486
Scientific Title Effect of restraint-free PET on stress responses and brain activities
Date of disclosure of the study information 2018/11/27
Last modified on 2019/03/29

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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