UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027579
Receipt number R000031378
Scientific Title A study of relationships between hierarchical sequence processing and executive function
Date of disclosure of the study information 2017/06/01
Last modified on 2021/12/03 11:23:21

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Basic information

Public title

A study of relationships between hierarchical sequence processing and executive function

Acronym

A study of hierarchical sequence processing

Scientific Title

A study of relationships between hierarchical sequence processing and executive function

Scientific Title:Acronym

A study of hierarchical sequence processing

Region

Japan


Condition

Condition

healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and neural mechanism of fMRI neurofeedback on hierarchical sequence processing.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Behavioral performance in fMRI neurofeedback tests

Key secondary outcomes

Structural and functional MRI data


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

fMRI scanning and neurofeedback
Up to 4 days, within 90 min per day

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

20 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Aged 20-35 years-old, male and female
2) Capability of informed consent
3) Right-handedness
4) Native Japanese speaker

Key exclusion criteria

1) Individuals with a neuropsychological, psychiatric or neurosurgical history
2) Individuals who are unable to undergo MRI

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiki Iwabuchi

Organization

Hamamatsu University School of Medicine

Division name

Research Center for Child Mental Development

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192 Japan

TEL

053-435-2331

Email

iwabuchi@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiki Iwabuchi

Organization

Hamamatsu University School of Medicine

Division name

Research Center for Child Mental Development

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192 Japan

TEL

053-435-2331

Homepage URL


Email

iwabuchi@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Graduate School of Letters, Hokkaido University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 06 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


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

Completed

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB

2017 Year 03 Month 13 Day

Anticipated trial start date

2017 Year 06 Month 15 Day

Last follow-up date

2023 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 31 Day

Last modified on

2021 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name