UMIN-CTR Clinical Trial

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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