UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058087 |
|---|---|
| Receipt number | R000066387 |
| Scientific Title | Accumulation of EEG data using a simple bipolar electroencephalograph and search for EEG features associated with depressive symptoms |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 10:28:16 |
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Basic information
Public title
Accumulation of EEG data using a simple bipolar electroencephalograph and search for EEG features associated with depressive symptoms
Acronym
Accumulation of EEG data using a simple bipolar electroencephalograph and search for EEG features associated with depressive symptoms
Scientific Title
Accumulation of EEG data using a simple bipolar electroencephalograph and search for EEG features associated with depressive symptoms
Scientific Title:Acronym
Accumulation of EEG data using a simple bipolar electroencephalograph and search for EEG features associated with depressive symptoms
Region
| Japan |
Condition
Condition
No target diseases (healthy individuals or individuals whose mental disorders are in remission)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy subjects will be evaluated using the PHQ-9, a self-rating scale for depression, and left and right frontal lobe EEG will be measured using a simple bipolar electroencephalograph, and a data set will be collected in which these data sets are tied together. These data sets will also be used to search for EEG features associated with depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Left and right frontal lobe EEG during each task/test (eye opening, eye closing, PHQ-9, mental rotation, Stroop task, silent reading of newspaper, Word fluency test, N-back task).
Key secondary outcomes
Patient Health Questionnaire-9(PHQ-9)
Mental rotation
Stroop task
Word fluency test
N-back task
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons who are 18 years of age or older at the time of obtaining consent
2) Persons who have given their consent of their own free will
Key exclusion criteria
1) Patients who are currently undergoing treatment for some mental disorder such as depression(regardless of past treatment)
2) Patients with a physical disease that makes it difficult to measure brain waves with a simple bipolar electroencephalograph(e.g., frontal skin disease, skull defect, etc.)
3) Persons who have or are undergoing treatment for diseases that may affect EEG(e.g., brain tumors, stroke, epilepsy, consciousness disorders, etc.)
4) Any other cases deemed inappropriate by the principal investigator or co-investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kishimoto |
| Middle name | |
| Last name | Taishiro |
Organization
Keio university school of medicine
Division name
Center for Promotion of Interdisciplinary Research in Medicine and life Science
Zip code
106-0041
Address
Mori JP Tower F7, 1-3-1, Azabudai, Minato-ku, Tokyo
TEL
03-5363-3219
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Kinoshita |
| Middle name | |
| Last name | Shotaro |
Organization
Keio university school of medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0041
Address
Mori JP Tower F7, 1-3-1, Azabudai, Minato-ku, Tokyo
TEL
03-5363-3219
Homepage URL
shotaro.kinoshita@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
FrontAct Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Faculty of Science and Technology, Keio University
FrontAct Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0353633503
med-rinri-jimu@adst.keio.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
慶應義塾大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 05 | 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
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Research design
Observational study
2. Recruitment
Two hundred healthy subjects will be evaluated using the PHQ-9, a self-rating scale for depression, and a simple bipolar electroencephalograph will be used to measure left and right frontal lobe electroencephalograms, and a data set will be collected in which these are tied together.
3. Outcomes
A) Background factors, clinical information, etc.
B) Measurement of electroencephalogram (EEG) using a simple EEG machine
C) The following tasks/examinations are performed while wearing the EEG equipment in B) above
Open eyes
Closed eyes
Filling out the PHQ-9
Cognitive function tests and tasks
4. Analysis
The EEG data obtained will be identified and noise introduced by noise reduction techniques developed by the research group will be removed from the EEG data obtained, and the EEG data will be transformed to each frequency using Fourier transform and Hilbert transform.
First, a comparison of the power spectra of those with and without depressive symptoms is made using biological statistics. When making comparisons, a comparison method that is more likely to show differences between the two groups will be explored, such as EEG throughout the entire EEG measurement or while performing a specific task.
Machine learning will also be attempted to determine depression and healthy subjects using time-domain and frequency-domain features.
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066387
