UMIN-CTR Clinical Trial

Public title

Association between altruism and change in frontal blood flow volume in Asperger syndrome.

Acronym

Association between altruism and change in frontal blood flow volume in Asperger syndrome.

Scientific Title

Association between altruism and change in frontal blood flow volume in Asperger syndrome.

Scientific Title:Acronym

Association between altruism and change in frontal blood flow volume in Asperger syndrome.

Region

Japan

Condition

Asperger syndrome

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Reliability is important to smoothly social life for individuals is a psychological element.Aspergar syndrome, but exhibits a failures of serious social communication such as "not fitted the line of sight" from infancy, this is also the aspect of failures of the "ability to trust others" in the same syndrome, the same syndrome patients with is considered to be a factor that will no longer be adapted to various problems in adolescence. Reliability refers to the action of the other, in a state where his body is compromised, and that the other party is to be expected that would not take such action, it is important to smoothly social life for individuals is a psychological element.Typically, Altruistic of trust to others, "without considering their losses, to be due to the other party, tend intended benefits of the other party" is to be in the background, and this Altruistic examination of Aspergar syndrome of the trust to others in syndrome, there is a possibility that can reveal the pathological aspects of thus social communication of failures.
Ultimatum game is one way to consider altruistic behavior of the person , the subject of money provided from the third party to the others having a veto a game to be dispensed. Set amount of money to distribute's freedom, but is not earned any reward to both if the other party has rejected.
This study, ultimatum game,is observed specificity for interest-communication, the difference between healthy adults in altruistic behavior observed in this game and, under the condition that under gaze of others, we study the impact on the results. At the same time, using the rating scale, each group trust degree others, to evaluate whether to trying risk in relation to the others. At the same time, near-infrared spectroscopy consider the relationship of the center and the blood flow and altruistic behavior the frontal lobe.

Basic objectives2

Others

Basic objectives -Others

The difference between the healthy adult in altruistic behavior observed in ultimatum game, also, under the condition that under the gaze of others, we examine the impact on its performance. At the same time, using the rating scale, such as trust rating scale, each group trust degree others, to evaluate whether to trying risk in relation to the others. At the same time, underwent NIRS, also examined the relationship of the center and the blood flow and altruistic behavior the frontal lobe.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changing pattern of oxygenated hemoglobin concentration of frontal lobe by NIRS during performance and game enforcement of Asperger's disorder and healthy adults in ultimatum game

Key secondary outcomes

Lonliness Scale
Trust Scale
Group mentality Scale
Japanese Adult Reading Test
Social Functioning Scale
Autism Spectrum Quotient AQ
Pervasive Developmental Disorders Autism Society Japan Rating Scale PARS
Conners'Adult ADHD Rating Scale CAARS
NIRS

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

Asperger syndrome patients who have been diagnosed on the basis of DSM at Showa University University Karasuyama hospital psychiatric or Showa University Hospital University Hospital East psychiatric outpatient to 20 years of age or less than 50-year-old adults in hospital. The contents of this study to understand, those who voluntarily obtained the consent of sentence.
And 20 years of age or less than 50 years of age adult. The contents of this study, we understand, was obtained consent voluntarily sentence persons. To fill the left of the criteria, it was control the group of patients and age, academic background and education environment and male-to-female ratio person.

Key exclusion criteria

Those who meet the diagnostic criteria for mental disorders other than Asperger syndrome DSM. Those who meet the diagnostic criteria of some personality disorders and mental retardation. Other serious neurological, who have a physical complications.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Ikuse

Organization

Showa University Karasuyama Hospital

Division name

Department of psychiatry

Zip code

Address

Setagaya-ku, Tokyo Kitakarasuyama 6-11-11

TEL

09034728105

Email

ikuself3211731@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Ikuse

Organization

Showa University Karasuyama Hospital

Division name

Department of psychiatry

Zip code

Address

Setagaya-ku, Tokyo Kitakarasuyama 6-11-11

TEL

03-3300-5231

Homepage URL

Email

ikuself3211731@yahoo.co.jp

Institute

Showa University Department of psychiatry

Institute

Department

Personal name

Organization

Showa University Department of psychiatry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

In the ultimatum game, participants in the healthy control group divided more money in eyespots condition than in no background and flower condition. However in Asperger group, there was no background effect.

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

Completed

Date of protocol fixation

2015

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective research

Registered date

2014

Year

12

Month

26

Day

Last modified on

2017

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018665