UMIN-ICDS Clinical Trial

Public title

Development of EEG Data Collection, Screening, and Symptom Quantification Technology for Specific Symptoms Associated with Depression and Anxiety: A Pilot Study

Acronym

Development of EEG Data Collection, Screening, and Symptom Quantification Technology for Specific Symptoms Associated with Depression and Anxiety: A Pilot Study

Scientific Title

Development of EEG Data Collection, Screening, and Symptom Quantification Technology for Specific Symptoms Associated with Depression and Anxiety: A Pilot Study

Scientific Title:Acronym

Development of EEG Data Collection, Screening, and Symptom Quantification Technology for Specific Symptoms Associated with Depression and Anxiety: A Pilot Study

Region

Japan

Condition

1. Patients with depressive, anxiety, and obsessive-compulsive and related disorders
2. Healthy Controls

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This pilot study aims to collect EEG signals using a wearable EEG device from healthy individuals and patients with depressive, anxiety, and obsessive-compulsive and related disorders, specifically under conditions where certain symptoms (rumination or obsessions) are likely to occur. By visualizing the EEG characteristics associated with these symptoms, we will develop a machine learning program for future symptom quantification and neurofeedback.

Basic objectives2

Others

Basic objectives -Others

As a pilot study, this research is conducted to assess the feasibility of the study protocol and to estimate the necessary sample size for a subsequent full-scale trial.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

- Resting-state EEG signals (eyes-open and eyes-closed conditions).

- EEG signals during Cognitive Behavioral Therapy (CBT) sessions, Exposure and Response Prevention (ERP).

- For the healthy control group: EEG signals during sessions involving instructions or physical activities similar to those provided to the patient group.

- Y-BOCS), or HAM-D/HAM-A and RRS

Key secondary outcomes

- Primary Diagnosis and Comorbidities
- Session markers and subjective symptoms during EEG recording
- Demographics (Gender, Age, Occupation, etc.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

For Patients:

1. Individuals aged 18 years or older diagnosed with any of the following according to DSM-5-TR criteria: depressive disorders, anxiety disorders, or obsessive-compulsive and related disorders accompanied by rumination or obsessions.

2. Individuals currently undergoing Cognitive Behavioral Therapy (CBT) focused on rumination or Exposure and Response Prevention (ERP) with a therapist, or performing these as structured homework assignments.

3. Individuals judged by their primary physician to have the capacity to provide informed consent.


For Healthy Controls:

1. Individuals with no history of psychiatric disorders who volunteered for the study via the recruitment website.

2. Individuals aged 18 years or older at the time of providing informed consent.

Key exclusion criteria

For Patients:

1. Individuals with physical conditions that interfere with EEG electrode placement or measurement (e.g., scalp dermatosis, cranial bone defects)

2. Individuals with neuropsychiatric (e.g., epilepsy, substance use disorders, organic brain disorders) or medical conditions (e.g. brain tumors, cerebral infarction, impaired consciousness, or traumatic brain injury) known to significantly affect EEG signals

3. Individuals currently undergoing treatments expected to significantly alter EEG results (e.g., Electroconvulsive Therapy [ECT], Transcranial Magnetic Stimulation [TMS], or use of anti-epileptic medications)

4. Individuals with severe suicidal ideation

5. Individuals whose primary diagnosis is a neuropsychiatric disorder other than those targeted in this study (e.g., schizophrenia)

6. Any other individuals determined by the principal investigator or sub-investigator to be unsuitable for the study


For Healthy Controls:

1. Individuals with physical conditions that interfere with EEG electrode placement or measurement (e.g., scalp dermatosis, cranial bone defects)

2. Individuals with neuropsychiatric (e.g., epilepsy, substance use disorders, organic brain disorders) or medical conditions (brain tumors, cerebral infarction, impaired consciousness, or traumatic brain injury) known to significantly affect EEG signals

3. Individuals currently undergoing treatments expected to significantly alter EEG results (e.g., ECT, TMS, or use of anti-epileptic medications)

4. Any other individuals determined by the principal investigator or sub-investigator to be unsuitable for the study

Target sample size

15

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Center for the Promotion of Interdisciplinary Research in Medicine and Life Science (PIRMS)

Zip code

1060041

Address

7F Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

TEL

03-5363-3492

Email

tkishimoto@keio.jp

Name of contact person

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Center for the Promotion of Interdisciplinary Research in Medicine and Life Science (PIRMS)

Zip code

1060041

Address

7F Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo 106-0041, Japan

TEL

03-5363-3492

Homepage URL

Email

tkishimoto@keio.jp

Institute

Keio University

Institute

Department

Personal name

Taishiro Kishimoto

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine Ethics Comittee

Address

35 Shinanomachi Shinjuku Tokyo

Tel

03-5363-3503

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学医学部大学院医学研究科付属医科学研究連携推進センター（東京都）
京都府立医科大学附属病院（京都府）
あさかホスピタル（福島県）
つつじメンタルホスピタル（群馬県）
あさか台メンタルクリニック（埼玉県）
大泉メンタルクリニック（東京都）
青山渋谷メディカルクリニック（東京都）
鶴が丘ガーデンホスピタル（東京都）
佐藤病院（山形県）
杉本医院からすまメンタルクリニック（京都府）
京都府立医科大学附属病院（京都府）

Date of disclosure of the study information

2026

Year

03

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

13

Day

Date of IRB

2026

Year

03

Month

13

Day

Anticipated trial start date

2026

Year

03

Month

25

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 related information

Observational study (Prospective cohort study)

In this study, EEG signals will be measured in two settings, within a medical facility and at the participants home, using a headphone-type wearable EEG device under multiple conditions. Specifically, EEG data will be collected during resting states while seated and during clinical interventions. These interventions include Rumination-Focused Cognitive Behavioral Therapy (RFCBT) and Exposure and Response Prevention (ERP) for depressive, anxiety and obsessive-compulsive disorders, as well as during related homework assignments.

Registered date

2026

Year

03

Month

19

Day

Last modified on

2026

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069724