UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029517 |
|---|---|
| Receipt number | R000033728 |
| Scientific Title | Neuroimaging database and gait analysis for disease in nervous system |
| Date of disclosure of the study information | 2017/10/19 |
| Last modified on | 2019/10/14 10:01:08 |
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Basic information
Public title
Neuroimaging database and gait analysis for disease in nervous system
Acronym
Neuroimaging database and gait analysis
Scientific Title
Neuroimaging database and gait analysis for disease in nervous system
Scientific Title:Acronym
Neuroimaging database and gait analysis
Region
| Japan |
Condition
Condition
Central nervous system disorders in general
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate neuropathology of central nervous system disorders
Basic objectives2
Others
Basic objectives -Others
To build neuroimaging database
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional connectivity by functional MRI
Key secondary outcomes
Motor function score, cognitive status score, quantitative measure of gait, other neuroimaging modalities such as SEPCT and cardiac MIBG synchigraphy and clinical data. These data is obtained as a cross-sectional study or longitudinal study over 3 months or more than 2 years.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with central nervous system disorders
2. Healthy subjects
Key exclusion criteria
Subjects who have other central nervous system disorders, or subjects with motion artifact in neuroimaging data
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yokota |
Organization
Tokyo Medical and Dental University
Division name
Department of neurology and neurological sciences
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
tak-yokota.nuro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Hattori |
Organization
Tokyo Medical and Dental Univeristy
Division name
Department of neurology and neurological sciences
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
takaaki-hattori@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental Univeristy, Department of neurology and neurological sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental Univeristy, Department of neurology and neurological sciences
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 Univeristy
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
info.bec@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M2017-127
Org. issuing International ID_1
Tokyo Medical and Dental Univeristy
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 19 | 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
| 2017 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033728
