UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034993
Receipt number 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 09:25:45

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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 or person

Institute

Hamamatsu Photonics K.K.

Institute

Department

Personal name



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

Value
https://center6.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