UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008968 |
|---|---|
| Receipt number | R000010518 |
| Scientific Title | Changes of autstic behaviors by neurofeedback method |
| Date of disclosure of the study information | 2012/09/24 |
| Last modified on | 2018/10/12 15:33:30 |
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Basic information
Public title
Changes of autstic behaviors by neurofeedback method
Acronym
Development of treatment of autism (NFB method)
Scientific Title
Changes of autstic behaviors by neurofeedback method
Scientific Title:Acronym
Development of treatment of autism (NFB method)
Region
| Japan |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neurofeedback is a non-invasive method in which participants change their brain activity based on online monitoring and feedback. We apply this method to adult individuals with autism spectrum disorders and evaluate associated behavioral changes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Facial expression judgement task (behavior, brain activity): Within 10 days after the completion of NF training
Key secondary outcomes
1. Behavioral Test (Facial Expression Rating)
2. Brain Function Test (Resting-state brain activity)
3.1. Liebowitz Social Anxiety Scale Japanese Version
3.2. Interpersonal Reactivity Index
3.3. State-Trait Anxiety Inventory
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
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Connectiivty neurofeedback
5 days, within 1 hour and 30 mins per day
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
(1) Patients with pervasive developmental disorders and/or Autism Spectrum Disorder that satisfy criteria of DSM-IV-TR or DSM-5.
(2) No major psychological and physical commorbidities
(3) Patients who understand the content of the study and voluntarily consent to participate.
(4) Patients who have the experience of participating the fMRI experiment and understand the psychological and physical stress associated with the fMRI experiment and still volunteer to participate in the study.
Key exclusion criteria
(1) When patient's primary physician judge the patients to be not qualified.
(2) When patients wear devices that are susceptable to high magnetic field of the MRI (such as artificial cardiac pacemaker, clip for aneurysms).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobumasa Kato |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research, Showa University Karasuyama Hospital
Zip code
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
TEL
03-3300-5231
katon@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichiro Hashimoto |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research, Showa University Karasuyama Hospital
Zip code
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo
TEL
03-3300-5231
Homepage URL
dbridges50@gmail.com
Sponsor or person
Institute
Showa Univeristy
Institute
Department
Personal name
Funding Source
Organization
SRPBS, MEXT
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
14-113
Org. issuing International ID_1
advanced telecommunications research institute international
Study ID_2
114-116
Org. issuing International ID_2
advanced telecommunications research institute international
IND to MHLW
Institutions
Institutions
昭和大学附属烏山病院（東京都）
国際電気通信基礎技術研究所（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 24 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010518
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