UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053032 |
|---|---|
| Receipt number | R000060494 |
| Scientific Title | Elucidating the pathology of neurodevelopmental disorders based on neuropsychological and neurophysiological functions |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/08 11:16:02 |
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Basic information
Public title
An investigation into the pathology of neurodevelopmental disorders using neuropsychological and neurophysiological assessments
Acronym
An investigation into the pathology of neurodevelopmental disorders using neuropsychological and neurophysiological assessments
Scientific Title
Elucidating the pathology of neurodevelopmental disorders based on neuropsychological and neurophysiological functions
Scientific Title:Acronym
Elucidating the pathology of neurodevelopmental disorders based on neuropsychological and neurophysiological functions
Region
| Japan |
Condition
Condition
neurodevelopmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the distinctive features of social cognitive function and time perceptual function in individuals with neurodevelopmental disorders through comparison with typically developing individuals.
Basic objectives2
Others
Basic objectives -Others
Investigating distinctions among neurodevelopmental disorders through comparisons between clinical groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral performance during tests of time perceptual function and social cognitive function in the neurodevelopmental and typically developing groups
Key secondary outcomes
1. Behavioral performance during tests of executive function and reward system function in the neurodevelopmental and typically developing groups
2. Clinical symptoms: Neurodevelopmental symptoms, anxiety, depression, neurosis, mania, social adjustment assessment
3. Neurophysiological characteristics: Brain structure, brain activity during resting-state and tasks, autonomic nerve activity
4. Background factors: Sex/Gender, age, diagnosis, medication, medication, intelligence test, developmental history, social support, caregiver's mental health
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
| 6 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male and female aged 6 to 55 years old.
2) Individuals diagnosed with a neurodevelopmental disorder by a specialist according to the diagnostic criteria of DSM-5 or ICD-10, who are attending outpatient clinics at the Department of Child Neurology at the National Center for Neurology and Psychiatry or affiliated research institutions, as well as those who have applied through public recruitment on the website.
3) Participants with a guardian capable of providing written consent, having received verbal and written explanations of the study's content. Additionally, individuals aged 18 or older, deemed to have sufficient decision-making capacity, have been provided with oral and written explanations of the study's content and have given written consent.
Key exclusion criteria
1) Individuals currently experiencing abnormalities in vision or hearing.
2) Persons with concurrent mental illnesses exhibiting unstable symptoms.
3) Individuals deemed by the principal investigator to be difficult to assess or participate in the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Okada |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry, Japan
Division name
Department of Developmental Disorders
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
+81-42-341-2157
tokada@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Okada |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry, Japan
Division name
Department of Developmental Disorders
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
+81-42-341-2157
Homepage URL
tokada@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology
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
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
Tel
+80-42-341-2712
rinri-jimu@ncnp.go.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
| 2023 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Cross-sectional, group-controlled study
Measurement item: Tests include assessments of time perceptual function, social cognitive function, executive function, and reward system function; MRI imaging; electroencephalography and event-related potentials; near-infrared spectroscopy (NIRS); intelligence tests; and questionnaires.
Management information
Registered date
| 2023 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060494
| 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 |
