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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042903
Receipt No. R000048975
Scientific Title Development of diagnostic technology for neurological disorders using a patch-type electroencephalograph
Date of disclosure of the study information 2021/01/06
Last modified on 2021/01/05

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Basic information
Public title Development of diagnostic technology for neurological disorders using a patch-type electroencephalograph
Acronym Development of diagnostic technology for neurological disorders using a patch-type electroencephalograph
Scientific Title Development of diagnostic technology for neurological disorders using a patch-type electroencephalograph
Scientific Title:Acronym Development of diagnostic technology for neurological disorders using a patch-type electroencephalograph
Region
Japan

Condition
Condition neuropsychiatric disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to develop the technology for differentiating neuropsychiatric disorders from electroencephalograph by applying statistical analysis / machine learning technology using electroencephalograph data measured by a patch-type electroencephalograph of patients and healthy subjects of Osaka University Hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of discrimination algorithm on neuropsychiatric disorders
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
120 years-old >=
Gender Male and Female
Key inclusion criteria 1)Age is 20 years old or older at the time of consent, regardless of gender.
2)After oral and written explanation, the subject has given written consent to participate.
3)Our hospital patients or healthy subjects
Key exclusion criteria 1) Those who are judged to be inappropriate for participation in this clinical study
2) Those who have an implantable device such as a pacemaker
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Ikeda
Organization Osaka University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 565-0871
Address 2-2, Yamadaoka, Suita, osaka, japan
TEL 0668793051
Email mikeda@psy.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Hata
Organization Osaka University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 565-0871
Address 2-2, Yamadaoka, Suita, osaka, japan
TEL 0668793051
Homepage URL
Email mhata@psy.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization PGV
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2, Yamadaoka, Suita, osaka, japan
Tel 0662108296
Email rinri@hp-crc.med.osaka-u.ac.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
2021 Year 01 Month 06 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 18 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048975

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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