UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055054 |
|---|---|
| Receipt number | R000062234 |
| Scientific Title | Study on the relationship between clinical course and imaging biomarkers in spinocerebellar degeneration and multiple system atrophy |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/23 06:24:47 |
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Basic information
Public title
Study on the relationship between clinical course and image findings in spinocerebellar degeneration and multiple system atrophy
Acronym
Stydy on the clinical course and image findings in spinocerebellar degeneration and multiple system atrophy
Scientific Title
Study on the relationship between clinical course and imaging biomarkers in spinocerebellar degeneration and multiple system atrophy
Scientific Title:Acronym
Study on the clinical course and imaging biomarkers in spinocerebellar degeneration and multiple system atrophy
Region
| Japan |
Condition
Condition
spinocerebellar degeneration and multiple system atrophy
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether clinical images measured over time are objective indicators of inter-individual variation in clinical severity and intra-individual change over time, and whether they serve as prognostic indicators of clinical symptom progression in patients with spinocerebellar degeneration and multiple system atrophy by retrospective analysis.
Basic objectives2
Others
Basic objectives -Others
Relation between clinical imaging and clinical course
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional Independence Measure(FIM), Scale for the assessment and rating of ataxia (SARA)
Key secondary outcomes
International Cooperative Ataxia Rating Scale (ICARS), Unified Multiple System Atrophy Rating Scale (UMSARS), Mini-mental State Examination (MMSE), Frontal Assessment Battery (FAB), 10 Meter Walking Test, Timed UP and Go test, Berg Balance Scale, 9-hole peg test, Box and Block Test, Maximum Phonation test, Goal Attainment Scale (GAS), etc
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 with spinocerebellar degeneration or multiple system atrophy who were admitted to Morinomiya Hospital from April 2008 to August 2023 and received short-term intensive rehabilitation.
Key exclusion criteria
Patients with whom MRI could not be conducted due to claustrophobia, disagreement with the examination, or other reasons.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88 Morinomiya, Jyoto-ku, Osaka, Japan.
TEL
06-6969-0111
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Hiramatsu |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88 Morinomiya, Jyoto-ku, Osaka, Japan.
TEL
06-6969-0111
Homepage URL
hiramatsu@omichikai.or.jp
Sponsor or person
Institute
Omichi-kai Social Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyama university hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel
06-6969-0111
nrri-jimu@omichikai.or.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
森之宮病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 24 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study
Spinocerebellar degeneration and multiple system atrophy patients who were admitted to Morinomiya Hospital between April 2008 and August 2023 and underwent short-term intensive rehabilitation will be included in the study. Cases in which MRI could not be performed due to metal in the body, claustrophobia, or disagreement with the examination will be excluded.
Background information (age, gender, diagnosis, disease duration), clinical evaluation(Functional Independence Measure(FIM),Scale for the assessment and rating of ataxia (SARA), Unified Multiple System Atrophy Rating Scale(UMSARS), International Cooperative Ataxia Rating Scale (ICARS), Mini-mental State Examination (MMSE), Frontal Assessment Battery (FAB),10 Meter Walking Test, Timed UP and Go test, Berg Balance Scale, 9-hole peg test, Box and Block Test, Maximum Phonation test, Goal Attainment Scale (GAS), etc) and MRI imaging (cerebellar hemisphere MR spectroscopy, brain atrophy rated by 3D morphological imaging, fractional anisotropy of the white matter fiber bundles measured by diffusion tensor imaging and functional connectivity measured by resting-state functional MRI) are evaluated.
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062234
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