UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032236 |
|---|---|
| Receipt number | R000036761 |
| Scientific Title | Brain imaging study about forgiveness |
| Date of disclosure of the study information | 2018/04/20 |
| Last modified on | 2023/04/17 11:33:33 |
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Basic information
Public title
Brain imaging study about forgiveness
Acronym
Brain imaging study about forgiveness
Scientific Title
Brain imaging study about forgiveness
Scientific Title:Acronym
Brain imaging study about forgiveness
Region
| Japan |
Condition
Condition
Autistic spectrum disorder (ASD)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify a theory that brain activities about forgiveness link to various neuropsychological features. Therefore, typical developed (TD) adults (male and female), elderly persons (TO) (male and female) and adults with autistic spectrum disorder (ASD) (male) would be participated in this study and they do various neuropsychological test batteries and fMRI measurements. Then, we discuss relations between factors (sexuality, characteristics, AQ and scores of various neuropsychological test batteries about forgiveness) and brain activities during forgiveness judgments from fMRI measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activation (BOLD signal changes)
Key secondary outcomes
1: Evaluation of generosity by dictator game
2: Character analysis by NEO-FFI (NEO Five-Factor Inventory)
3: Scale of J-PAM (Proclivity to Apologize Measure)
4: Scale of J-TRIM (Transgression-Related Interpersonal Motivations)
5: Scale of J-TFS (Trait Forgivingness Scale)
6:IQ from WAIS-III
7: Autistic Quotient from AQ test
8: Brain volumes processed by VBM
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
fMRI measurements during the task of forgiveness and neuropsychological test batteries
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1: Participants aged 20 to 45 (TD persons and ASD males) and 65-85 (elderly persons)
2: right-handedness
3: Individuals who are consent to participate in this study
4:Individuals who have no history of psychiatric disease (both TD and elderly persons)
5:Individuals who are already diagnosed as ASD (ASD males)
Key exclusion criteria
1:(both TD and TO)individuals who have a history of traumatic brain injury with an unconsciousness lasting more than 5 min.
2:(both TD and TO)individuals who have a history of organic brain disease
3:(both TD and TO)individuals who have a history of psychiatric disease
4:(both TD and TO)individuals who have a history of substance dependence
5:(both TD and TO)individuals who are taking central nervous system stimulants
6:(both TD and TO)individuals who have a history of disorders of consciousness and /or seizure
7:(both TD and TO)individuals who have a chronic headache
8:(ASD)individuals who are on medication on the day for MRI measurement
9:(ALL)Individuals who have a risk for MRI scan
(1)Individuals who had surgery to insert a pacemaker
(2)individuals who had a metallic artificial cardiac valve replacement
(3)individuals who insert an artificial inner ear and/or an artificial inner ossicle
(4)individuals who use an equipment for deep brain stimulation and/or transcutaneous electrical nerve stimulation
(5)Individuals who mount an electrical bone growth stimulator.
(6)individuals who use an injection pump
(7)individuals who insert an artificial eye body which mounted by magnetic force and insert fake tooth which remove its magnetic parts
(8)It takes less than 2 months since a magnetic stent is inserted into a coronary artery etc
(9)Intracephalic aneurysm clip and/or coil remains
(10)individuals who have any other metals in their body
(11)individuals who are suffering from claustrophobia
(12)individuals who have tattoos
10: (ALL)individuals whom a researcher does not decide to suit to participate in
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu University School of medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Hiraishi |
Organization
Hamamatsu University School of medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
Homepage URL
hiraishi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of medicine
Department of Biofunctional Imaging
Institute
Department
Personal name
Funding Source
Organization
MEXT(JAPAN)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation
Hamamatsu Photonics K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu university School of Medicine
Address
1-20-1, handayama, higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学（静岡県） Hamamatsu University School of Medicine (Shizuoka Pref.)
浜松PET診断センター（静岡県）Hamamatsu PET Imaging Center (Shizuoka Pref.)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 20 | 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 | 12 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 19 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036761
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