UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034594
Receipt number R000039442
Scientific Title Benefits of neuro-feedback-cognitive training using NIRS on cognitive function
Date of disclosure of the study information 2018/10/22
Last modified on 2021/04/24 09:36:15

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Basic information

Public title

Benefits of neuro-feedback-cognitive training using NIRS on cognitive function

Acronym

Benefits of neuro-feedback-cognitive training

Scientific Title

Benefits of neuro-feedback-cognitive training using NIRS on cognitive function

Scientific Title:Acronym

Benefits of neuro-feedback-cognitive training

Region

Japan


Condition

Condition

Healthy young adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the benefit of neuro-feedback cognitive training on cognitive functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Score of processing speed test

Key secondary outcomes

Cognitive function(FAB, stroop, verbal fluency, Raven, JART, Logical memory, digit span, D-CAT, symbol search, digit symbol coding, mental rotation)

Brain activation by NIRS

Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D, daily habits, effortful control)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

cognitive training with neuro-feedback (20 minutes game, everyday per week for 6 weeks)

Interventions/Control_2

cognitive training without neuro-feedback (20 minutes game, everyday per week for 6 weeks)

Interventions/Control_3

active control(20 minutes game, everyday per week for 6 weeks)

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

right handed Japanese young adults who play video game less than 1 hour per week past 2 years

Key exclusion criteria

We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease.
The subject participated in other intervention study within 2 months.
The subject can not write the game diary everyday and can not take pre- and post- assessments.

Target sample size

84


Research contact person

Name of lead principal investigator

1st name Rui
Middle name
Last name Nouchi

Organization

Tohoku University

Division name

SARC

Zip code

980-8575

Address

Sendai, seiryo-machi 4-1

TEL

022-717-8952

Email

rui.nouchi.a4@tohoku.ac.jp


Public contact

Name of contact person

1st name Rui
Middle name
Last name Nouchi

Organization

Tohoku Univeristy

Division name

SARC

Zip code

985-8575

Address

Sendai, seiryo-machi 4-1

TEL

022-717-8952

Homepage URL


Email

rui.nouchi.a4@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

NeU

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate School of Medicin

Address

Seiryo2-1, Sendai, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2018 Year 10 Month 22 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

2018 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2021 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 22 Day

Last modified on

2021 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name