UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043450 |
|---|---|
| Receipt number | R000048525 |
| Scientific Title | Evaluation of neural circuits and chemical substances in the brain in neurodevelopmental disorders using MRI |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2025/01/20 11:49:32 |
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Basic information
Public title
Elucidation of the pathophysiology of neurodevelopmental disorders by imaging analysis
Acronym
Elucidation of the pathophysiology of neurodevelopmental disorders by imaging analysis
Scientific Title
Evaluation of neural circuits and chemical substances in the brain in neurodevelopmental disorders using MRI
Scientific Title:Acronym
Evaluation of neural circuits and chemical substances in the brain in neurodevelopmental disorders using MRI
Region
| Japan |
Condition
Condition
Neurodevelopmental disorders
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
MRI imaging analysis will be performed on cases in which the causative variant has been identified. By acquiring detailed data on neural circuits and chemical substances in the brain, we will clarify the pathological mechanism.
Basic objectives2
Others
Basic objectives -Others
Comparing brain structures, neural circuits, and brain chemicals between patient and healthy siblings
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain structure data by MRI
Neural circuit data by diffusion tensor imaging
Measurement of chemical substances in the brain by MR spectroscopy
Key secondary outcomes
The medical information on height, weight, age, gender, complications, developmental index, and past MRI findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Sedatives should be given for MRI examination (intravenous administration for the patient group; oral or suppository for healthy sibs)
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient group
Patients whose causative gene abnormalities have already been identified by genetic analysis for the diagnosis of neurodevelopmental disorders.
Healthy siblings
Those who have not been diagnosed with neurodevelopmental disorders
Key exclusion criteria
1. Persons with diseases for which safety cannot be guaranteed by participating in the study
2. Persons with physical conditions for which safety cannot be guaranteed by participating in the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hirotomo |
| Middle name | |
| Last name | Saitsu |
Organization
Hamamatsu University school of medicine
Division name
Department of Biochemistry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2327
hsaitsu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotomo |
| Middle name | |
| Last name | Saitsu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biochemistry
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2327
Homepage URL
hsaitsu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of medicine
Department of Biochemistry
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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, Japan
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.)
浜松ホトニクス株式会社(静岡県）Hamamatsu Photonics K.K (Shizuoka Pref.)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
1
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
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048525
