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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032588
Receipt No. R000037160
Scientific Title Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Date of disclosure of the study information 2018/05/14
Last modified on 2019/05/15

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Basic information
Public title Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Acronym Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
Scientific Title:Acronym Near-infrared time-resolved spectroscopy study on measurement of deep brain regions
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 capability of time-resolved spectroscopy (TRS) on evaluation of deep brain regions by comparing TRS-derived hemodynamic data with cerebral blood and volume data measured by positron emission tomography (PET).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemoglobin concentration and tissue oxygen saturation measured by time-resolved spectroscopy.
Cerebral blood volume and cerebral blood flow by PET.
Key secondary outcomes Relationship between the levels of hemoglobin concentration at the forehead and the deep brain tissue.

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 hemodynamic data from the time resolved spectroscopy system and cerebral blood flow/ volume from the PET system during motor, cognitive and sensory tasks.
MRI measurement during the resting state.
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1.A healthy adult (20 years old and over, 59 years old or younger).
2.Individuals who are consent to participate in this study.
Key exclusion criteria 1.Individuals who are judged inadequacy for participation of this study by doctor or research director.
2.Individuals who have one or multiple following diagnosis: dementia, mild degree of dementia, brain damage, Parkinson disease, psychiatric disease and claustrophobia.
3.Individuals who have one or multiple following symptoms or disease: hearing difficulty, impaired vision and finger tremor.
4.Individuals whose heads with TRS probes on cannot be placed safely into the gantry of the PET camera.
5.Individuals who are judged inadequacy for participation of MRI examination by doctor or operator from the MRI checklist results.
6.Individuals who are pregnant or having a possibility of pregnancy.

Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yukio
Middle name
Last name Ueda
Organization Hamamatsu Photonics K.K.
Division name The 7th Research Group, Central Research Laboratory
Zip code 4348601
Address 5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL 053-586-7111
Email ueda@crl.hpk.co.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Suzuki
Organization Hamamatsu Photonics K.K.
Division name The 7th Research Group, Central Research Laboratory
Zip code 4348601
Address 5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka, Japan
TEL 053-586-7111
Homepage URL
Email hiro-su@crl.hpk.co.jp

Sponsor
Institute Hamamatsu Photonics K.K.
Institute
Department

Funding Source
Organization Self funding
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 Hamamatsu Medical Photonics Foundation.
Address 5000, Hirakuchi Hamakita-ku, Hamamatsu City, Shizuoka, Japan
Tel 053-584-6581
Email takagi@hmp.or.jp

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 05 Month 14 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 8
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
2018 Year 03 Month 30 Day
Date of IRB
2018 Year 03 Month 30 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 14 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037160

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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