UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022361
Receipt number R000025772
Scientific Title Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.
Date of disclosure of the study information 2016/05/19
Last modified on 2019/11/21 11:16:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.

Acronym

Neural basis of inferring the impact of remark in communication on listener in autism.

Scientific Title

Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.

Scientific Title:Acronym

Neural basis of inferring the impact of remark in communication on listener in autism.

Region

Japan


Condition

Condition

Autism Spectrum Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the neural basis of evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener.

Basic objectives2

Others

Basic objectives -Others

To reveal the specific brain region related to evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener in adults with autism using functional MRI technique.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Task performance and functional brain image.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Adults with Autism Spectrum Disorder.

Interventions/Control_2

Typically developed adults.

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

18 years-old <=

Age-upper limit

26 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients
1) Adults who were diagnosed as autism spectrum disorder based on DSM-IV-TR or DSM-5, and confirmed the diagnosis by AQ.
2) Adults who do not have any severe neuropsychiatric disorders and physical illness.
3) Adults whose IQs are above 70, and who can give informed consent.

Typical control
1) Adults who do not have any severe neuropsychiatric disorders and physical illness.
2) Adults whose IQs are above 70, and who can give informed consent.

Key exclusion criteria

Adults who has diagnoses as neuropsychiatric disorder and intellectual disorder, who is extreme myopia, who is pregnant, who have metal thing in a surface of a body, who can't control body temperatures adequately and who don't have ability to consent.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Taki

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Nuclear Medicine and Radiology

Zip code

980-8575

Address

4-1 Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-8556

Email

yasuyuki.taki.c7@tohoku.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Kobayashi

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Nuclear Medicine and Radiology

Zip code

980-8575

Address

4-1 Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-3572

Homepage URL


Email

akiko.kobayashi.q6@dc.tohoku.ac.jp


Sponsor or person

Institute

Institute of Development, Aging and Cancer, Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Institute of Development, Aging and Cancer, Tohoku University

Organization

Division

Category of Funding Organization

Other

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 Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, 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

2016 Year 05 Month 19 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

41

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

2016 Year 05 Month 11 Day

Date of IRB

2016 Year 05 Month 11 Day

Anticipated trial start date

2016 Year 05 Month 19 Day

Last follow-up date

2019 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

2016 Year 05 Month 19 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name