UMIN-ICDS Clinical Trial

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

Impulse control disorders and child maltreatment

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

150

Name of lead principal investigator

1st name	Aya
Middle name
Last name	Isumi

Organization

Tokyo Medical and Dental University

Division name

Department of Global Health Promotion

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5187

Email

Isumi.hlth@tmd.ac.jp

Name of contact person

1st name	Yuto
Middle name
Last name	Maeda

Organization

Tokyo Medical and Dental University

Division name

Department of Global Health Promotion

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5187

Homepage URL

Email

maedhlth@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

VIE Co., Ltd

Name of secondary funder(s)

Organization

Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5096

Email

syomu1.adm@tmd.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

東京医科歯科大学

Date of disclosure of the study information

2024

Year

03

Month

01

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

2024

Year

02

Month

29

Day

Date of IRB

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

01

Month

25

Day

Last modified on

2024

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060812