UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061157 |
|---|---|
| Receipt number | R000069984 |
| Scientific Title | A multicenter observational study on the construction of an EEG registry and exploration of diagnostic technologies for neurological and psychiatric disorders based on patch-based EEG measurement |
| Date of disclosure of the study information | 2026/04/04 |
| Last modified on | 2026/04/04 12:01:58 |
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Basic information
Public title
Registry construction and exploratory diagnostic research using patch-based EEG measurement in neurological and psychiatric disorders
Acronym
Patch EEG Registry Study
Scientific Title
A multicenter observational study on the construction of an EEG registry and exploration of diagnostic technologies for neurological and psychiatric disorders based on patch-based EEG measurement
Scientific Title:Acronym
Patch-EEG NeuroPsych Registry
Region
| Japan |
Condition
Condition
Neurological and psychiatric disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to systematically collect and accumulate EEG data obtained using a patch-based EEG device from patients with neurological and psychiatric disorders and from healthy adults, and to construct an EEG registry for neurological and psychiatric disorders. In addition, by linking the collected EEG data with clinical and sleep-related information and applying statistical analysis and machine-learning techniques, we aim to explore differential diagnosis and diagnostic technologies for neurological and psychiatric disorders.
Basic objectives2
Others
Basic objectives -Others
Construction of an EEG registry and exploration of diagnostic technologies
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG measurement completion rate and missing rate of mandatory data items, assessed at the time of patch-based EEG measurement. These outcomes will be described as proportions (%) according to measurement setting (outpatient, inpatient, or home) and measurement type (short-duration, long-duration, or overnight).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adults aged 20 years or older at the time of informed consent.
2) Individuals who provide written informed consent for study participation.
3) Patients with neurological or psychiatric disorders who visit or are admitted to a participating study institution between April 2026 and March 2030, or healthy adults.
Key exclusion criteria
1) Individuals with implanted devices such as a pacemaker.
2) Individuals considered inappropriate for participation by the principal investigator or sub-investigators.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2 D3 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3051
mhata@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2 D3 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3051
Homepage URL
mhata@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Science and Technology Agency
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Observational Studies, Osaka University Hospital
Address
2-2Yamadaoka, Suita, Osaka, Japan
Tel
+81-6-6210-8270
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
大阪大学医学部附属病院（大阪府）、浅香山病院（大阪府）、小阪病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 04 | 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
| 2026 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study, and study initiation at each participating institution will occur after approval by the head of each institution.
Management information
Registered date
| 2026 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069984
