UMIN-CTR Clinical Trial

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
Email	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
Email	motoaki@med.showa-u.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development (AMED)
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045754