UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053240 |
|---|---|
| Receipt number | R000060755 |
| Scientific Title | Research on neurological disease using neuroimaging database and movement analysis |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2023/12/27 13:01:59 |
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Basic information
Public title
Research on neurological disease using neuroimaging database and movement analysis
Acronym
Neuroimaging and movement analysis for neurological disease
Scientific Title
Research on neurological disease using neuroimaging database and movement analysis
Scientific Title:Acronym
Neuroimaging and movement analysis for neurological disease
Region
| Japan |
Condition
Condition
neurological disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to better understand the pathogenesis, recognize disease specific pattern, improve diagnositic accuracy and evaluate therapeutic effects by using neuroimaging database and movement analysis.
Basic objectives2
Others
Basic objectives -Others
To improve diagnostic accuracy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will obtrain neuroimaing, gait data, acceleration and video, but we donot determine specific primary outcomes since this is exploratory design.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI(3T) from one to eight times per year
Interventions/Control_2
wearable divice and video from one to eight times per year
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with neurological diasease and helathy subjects who conset to have MRI and/or movement analysis
Key exclusion criteria
Subjects who have a mental that is not compatbile with MRI in body, and/or claustrophobia
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Hattori |
Organization
Tokyo Medical and Dental University
Division name
Department of neurology and neurological science
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
hattorit.nuro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Hattori |
Organization
Tokyo Medical and Dental University
Division name
Department of neurology and neurological science
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
hattorit.nuro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Takaaki Hattori
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
hattorit.nuro@tmd.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
| 2024 | Year | 04 | 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
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060755
