UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between altruism and change in frontal blood flow volume in Asperger syndrome.
Title of the study (Brief title)	Association between altruism and change in frontal blood flow volume in Asperger syndrome.
Region	Japan

Condition
Condition	Asperger syndrome
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Daisuke Ikuse
Organization	Showa University Karasuyama Hospital
Division name	Department of psychiatry
Address	Setagaya-ku, Tokyo Kitakarasuyama 6-11-11
TEL	09034728105
Email	ikuself3211731@yahoo.co.jp

Public contact
Name of contact person	Daisuke Ikuse
Organization	Showa University Karasuyama Hospital
Division name	Department of psychiatry
Address	Setagaya-ku, Tokyo Kitakarasuyama 6-11-11
TEL	03-3300-5231
Homepage URL
Email	ikuself3211731@yahoo.co.jp

Sponsor
Institute	Showa University Department of psychiatry
Institute
Department

Funding Source
Organization	Showa University Department of psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
Other related information	Prospective research

Management information
Registered date	2014 Year 12 Month 26 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018665