UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053437 |
|---|---|
| Receipt number | R000060812 |
| Scientific Title | Impulsivity Control via Neurofeedback using wearable electroencephalogram : A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/08/18 13:27:05 |
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Basic information
Public title
Impulsivity Control Using Neurofeedback
Acronym
Impulsivity Control Using Neurofeedback
Scientific Title
Impulsivity Control via Neurofeedback using wearable electroencephalogram : A Randomized Controlled Trial
Scientific Title:Acronym
Impulsivity Control using Neurofeedback: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Impulse control disorders and child maltreatment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of neurofeedback, which measures the brain waves of participants and feeds them back to themselves, on impulse control when a child continues to cry and does not stop.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impulsivity to child's crying and gagging
Key secondary outcomes
Abusive behavior including physical abuse, psychological abuse, and neglect, parenting stress, parenting difficulties, and the way of communication with children
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Using earphone-type wearable electroencephalographs (EEGs), participants' brain waves are measured twice: once while listening to a child crying and once while listening to natural environmental sounds like birds chirping.
A program is developed to determine each participant's states of irritation and calmness based on these two measurements.
While measuring brain waves, this program is used to conduct real-time neurofeedback (NF) training.
The participants' brain wave states are indicated by the size of a red circle. The size of the circle reflects how closely the brain activity matches that of an irritated state.
Participants train to keep the diameter of the red circle, representing their brain waves, smaller than the threshold indicated by a blue color while listening to a child crying.
Interventions/Control_2
Using earphone-type wearable electroencephalographs (EEGs), participants' brain waves are measured twice: once while listening to a child crying and once while listening to natural environmental sounds like birds chirping.
A program is developed to determine each participant's states of irritation and calmness based on these two measurements. However, this program is not used in the training among control group.
The control group, like the intervention group, listens to the child's cries and is instructed to focus on breathing while staring at a cross (concentration point) that appears on the screen while the EEG is measured.
The EEG status is not displayed on the screen, only measured.
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
Mothers and fathers with 2-3 year old children
Key exclusion criteria
Those who cannot understand Japanese
Those who are undergoing treatment for mental disorder and are judged by the principal investigator to be unable to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Isumi |
Organization
Institute of Science Tokyo
Division name
Department of Public Health
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5187
Isumi.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Maeda |
Organization
Institute of Science Tokyo
Division name
Department of Public Health
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5187
Homepage URL
maedhlth@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
VIE Co., Ltd
Name of secondary funder(s)
Nippon Life Insurance Foundation
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
東京科学大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | 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
74
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060812
