UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033013
Receipt number R000037613
Scientific Title Functional imaging study on autobiographical memory
Date of disclosure of the study information 2018/06/18
Last modified on 2022/12/23 15:37:26

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Basic information

Public title

Functional imaging study on autobiographical memory

Acronym

Neural basis of autobiographical memory

Scientific Title

Functional imaging study on autobiographical memory

Scientific Title:Acronym

Neural basis of autobiographical memory

Region

Japan


Condition

Condition

Typically developed

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to understand neural mechanism of autobiographical memory, we record brain activity during recollection and simulation of autobiographical memory using MRI.

Basic objectives2

Others

Basic objectives -Others

We measure physiological activity and collect behavioral data and examine relationship between brain activity and physiological and behavioral measures.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

functional MRI

Key secondary outcomes

structural MRI
skin conductance response
autobiographical memory test


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

To record brain activity using fMRI

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

30 years-old >

Gender

Male and Female

Key inclusion criteria

1. No serious comorbid psychiatric disorders or medical illness.
2. Capability of informed consent
3. Aged 20-49 years-old, male and female who satisfied conditions 1-2.

Key exclusion criteria

subjects who are deemed inappropriate for fMRI research.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Ryuichiro
Middle name
Last name Hashimoto

Organization

Showa University

Division name

Medical Institute of Developmental Disabilities Research

Zip code

151-0071

Address

6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan

TEL

03-5315-9357

Email

ihashimoto-r@umin.ac.jp


Public contact

Name of contact person

1st name Ryuichiro
Middle name
Last name Hashimoto

Organization

Showa University

Division name

Medical Institute of Developmental Disabilities Research

Zip code

151-0071

Address

6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan

TEL

03-5315-9357

Homepage URL


Email

ihashimoto-r@umin.ac.jp


Sponsor or person

Institute

Showa Unviersity

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Education, Culture, Sports, Science and Technology of Japan, the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo Metropolitan University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Showa University

Address

6-11-11 kitakarasuyama, setagaya-ku,tokyo

Tel

03-3300-5247

Email

nhanazawa@cnt.showa-u.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 06 Month 18 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

2018 Year 06 Month 15 Day

Date of IRB

2018 Year 05 Month 23 Day

Anticipated trial start date

2018 Year 06 Month 18 Day

Last follow-up date

2021 Year 07 Month 31 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 06 Month 15 Day

Last modified on

2022 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037613


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name