UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061433 |
|---|---|
| Receipt number | R000070292 |
| Scientific Title | A retrospective observational study of the natural history and the effects of early diagnosis and treatment of pediatric neurological disorders. |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/01 14:46:45 |
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Basic information
Public title
A retrospective observational study of the natural history and the effects of early diagnosis and treatment of pediatric neurological disorders.
Acronym
A retrospective observational study of the natural history and the effects of early diagnosis and treatment of pediatric neurological disorders.
Scientific Title
A retrospective observational study of the natural history and the effects of early diagnosis and treatment of pediatric neurological disorders.
Scientific Title:Acronym
A retrospective observational study of the natural history and the effects of early diagnosis and treatment of pediatric neurological disorders.
Region
| Japan |
Condition
Condition
Pediatric neurological diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study will investigate differences in clinical presentation, treatment response, and long-term prognosis among children diagnosed with pediatric neurological disorders at our hospital, including cases diagnosed after the onset of symptoms and cases diagnosed before symptoms appeared. The aim is to examine factors influencing disease prognosis and contribute to the development of better medical care systems and guidelines for the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of activities of daily living (ADL) (Functional independence assessment scale, pediatric assessment scale)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with pediatric neurological disorders who are receiving treatment at our hospital:
Target diseases: Spinal muscular atrophy, spinocerebellar degeneration, myasthenia gravis, muscular dystrophy, congenital myopathy, epilepsy, tuberous sclerosis, acute encephalitis/encephalopathy, hypoxic-ischemic encephalopathy, neurodevelopmental disorders, mitochondrial diseases, congenital metabolic disorders, hereditary dystonia, chromosomal abnormalities, fragile X syndrome, congenital malformation syndromes, neurodevelopmental disorders, chronic fatigue syndrome, orthostatic dysregulation, Long COVID, etc.
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Nakamura |
Organization
University of the Ryukyus
Division name
Graduate School of Medicine Department of Developmental Medicine
Zip code
901-2222
Address
1076 Kiyama, Ginowan City, Okinawa Prefecture
TEL
0988941417
h071341@cs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Nakamura |
Organization
University of the Ryukyus
Division name
Graduate School of Medicine Department of Developmental Medicine
Zip code
901-2222
Address
1076 Kiyama, Ginowan City, Okinawa Prefecture
TEL
0988941417
Homepage URL
n.sadao39@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
1076 Kiyama, Ginowan City, Okinawa Prefecture
Tel
0988941417
h071341@cs.u-ryukyu.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
沖縄県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | 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
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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study will investigate differences in clinical presentation, treatment response, and long-term prognosis among children diagnosed with pediatric neurological disorders residing in Okinawa Prefecture, including cases diagnosed after onset and those diagnosed before symptoms appeared. The study will examine factors influencing disease prognosis and contribute to the development of better medical care systems and guidelines for the future.
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070292
