UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030304 |
|---|---|
| Receipt number | R000030265 |
| Scientific Title | Investigation on relationship between state evaluation of psychiatric disorder and brain function using automatic recognition technology with artificial intelligence. |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2023/06/13 10:53:54 |
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Basic information
Public title
Investigation on relationship between state evaluation of psychiatric disorder and brain function using automatic recognition technology with artificial intelligence.
Acronym
Study on relationship between psychiatric disorder and brain function by artificial intelligence
Scientific Title
Investigation on relationship between state evaluation of psychiatric disorder and brain function using automatic recognition technology with artificial intelligence.
Scientific Title:Acronym
Study on relationship between psychiatric disorder and brain function by artificial intelligence
Region
| Japan |
Condition
Condition
psychiatric disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate the relationship between the characteristics of brain activation and the emotional changes during the social cognition task using artificial intelligence analysis.
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the correlation values of the emotional expression change of the video image and hemodynamic change in the frontal and temporal region among psychiatric patients and healthy controls.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a. or b.
A. Among patients visiting or hospitalized at Gunma University Hospital who has been diagnosed as a corresponding psychiatric disorder in accordance with DSM-5 and has been informed of the disorder or a state.
B. Normal people who are free from mental illness and neurological disorder in the present and past.
Key exclusion criteria
1) Under 15 years old
2) Merging serious physical disorders
3) Measures Inpatients
4) Emergency hospitalized patients
5) Others judged inappropriate as subjects by doctors
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fukuda |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunm a 371-8511, Japan
TEL
027-220-8180
fukuda-psy@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Suda |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunm a 371-8511, Japan
TEL
027-220-8180
Homepage URL
sudamasashi7@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22 Showa, Maebashi, Gunma, Japan
Tel
0272204172
hitotaisho-ciru@ml.gunma-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
| 2017 | Year | 12 | Month | 08 | 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
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | 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
Nothing
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030265
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
