UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050207 |
|---|---|
| Receipt number | R000057176 |
| Scientific Title | Research on diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders by EEG analysis |
| Date of disclosure of the study information | 2023/02/02 |
| Last modified on | 2023/02/01 10:28:58 |
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Basic information
Public title
Research on diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders by EEG analysis
Acronym
Research on diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders by EEG analysis
Scientific Title
Research on diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders by EEG analysis
Scientific Title:Acronym
Research on diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders by EEG analysis
Region
| Japan |
Condition
Condition
patients with neuropsychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will apply artificial intelligence and other analysis methods to EEG data measured at Osaka University hospital to develop technologies to examine the diagnosis, treatment efficacy, and prognosis of neuropsychiatric disorders based on EEG.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between EEG and diagnosis, treatment efficacy, and prognosis of 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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects will be included whose EEG was measured at Osaka University Hospital between April 1, 2009 and March 31, 2026 for clinical or other reasons, with no restrictions on age or gender. EEGs of subjects who were found to be healthy as a result of the examination are also included.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
Department of Psychiatry, Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2 D3 Yamadaoka, Suita-shi, Osaka
TEL
0668793051
mhata@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
Department of Psychiatry, Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2 D3 Yamadaoka, Suita-shi, Osaka
TEL
0668793051
Homepage URL
mhata@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Ethics Review Committee
Address
4F, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
06-6210-8296
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
| 2023 | Year | 02 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057176
