UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040138 |
|---|---|
| Receipt number | R000045754 |
| Scientific Title | Neural basis of therapeutic intervention in neurodevelopmental disorders |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2021/12/10 09:48:59 |
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Basic information
Public title
Neural basis of therapeutic intervention in neurodevelopmental disorders
Acronym
Neural basis of therapeutic intervention in neurodevelopmental disorders
Scientific Title
Neural basis of therapeutic intervention in neurodevelopmental disorders
Scientific Title:Acronym
Neural basis of therapeutic intervention in neurodevelopmental disorders
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to investigate neural basis of therapeutic interventions such as medication and group therapy for neurodevelopmental disorders including ASD and ADHD. For this purpose, MRI and clinical / cognitive data are longitudinally evaluated before and after a treatment in clinical practice. MRI data include fMRI, resting-state fMRI, structural MRI and Diffusion Tensor Imaging (DTI).
Basic objectives2
Others
Basic objectives -Others
Brain Information
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MRI data (fMRI, resting-state fMRI, structural MRI, and DTI)
Key secondary outcomes
Clinical and Cognitive data
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. ASD and ADHD patients diagnosed by specialists based on DSM-5. Typically developed healthy subjects who agree to participate in this study.
2. Subjects who did not have any serious neuropsychiatric disorders, except for neurodevelopmental disorders, and severe physical illness.
3. Subjects who can understand this study and give written informed consent. A subject under the age of 20 needs informed consent from a legal representative.
4. Age more than 15 years old.
Key exclusion criteria
1. Subjects who are regarded inappropriate as a participant by attending psychiatrists.
2. Subjects who fall into the followings; cardiac pacemaker, cerebral artery clip, Implanted medical devices (ICD, cochlear implant, nerve stimulator, other), implanted infusion pump, embedded metal in the body, pregnancy or possibly pregnant, tattoos, permanent makeup and so on. These potential risks for MRI scan are screened by Medical Questionnaire for MRI Scan.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kato |
| Middle name | |
| Last name | Nobumasa |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
6-11-11, Kita-karasuyama, Setagaya, Tokyo 157-8577, JAPAN
TEL
0353159357
katon@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Motoaki |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
6-11-11, Kita-karasuyama, Setagaya, Tokyo 157-8577, JAPAN
TEL
0353159357
Homepage URL
motoaki@med.showa-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development (AMED)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Showa University, Karasuyama Hospital
Address
6-11-11, Kita-karasuyama, Setagaya, Tokyo 157-8577, JAPAN
Tel
03-3300-5247
scri@ofc.showa-u.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
| 2020 | Year | 04 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this observational study, MRI and clinical / cognitive data are longitudinally collected before and after treatment selected in clinical practice of neurodevelopmental disorders such as ASD and ADHD. MRI data include fMRI, resting-state fMRI, structural MRI and DTI. Clinical / cognitive evaluations include ADOS-2, CAARS, CANTAB and so on.
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045754
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
