UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035852 |
|---|---|
| Receipt number | R000039301 |
| Scientific Title | An observational study of brain activity changes before and after surgery of cervical spondylosis. |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2024/03/07 12:49:58 |
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Basic information
Public title
An observational study of brain activity changes before and after surgery of cervical spondylosis.
Acronym
A study of brain activity before and after surgery of cervical spondylosis.
Scientific Title
An observational study of brain activity changes before and after surgery of cervical spondylosis.
Scientific Title:Acronym
A study of brain activity before and after surgery of cervical spondylosis.
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation of changes in brain activity and connectivity.
Basic objectives2
Others
Basic objectives -Others
Observation of changes in status.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant differences in MR imaging markers between pre- and post-surgery.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with JOA scores of 6 - 12 before surgery and age- & sex-matched healthy control subjects.
Key exclusion criteria
Those who are contraindicated to the MRI scan.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University
Division name
Human Brain Research Center
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3695
tomokada@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University
Division name
Human Brain Research Center
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3695
Homepage URL
tomokada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoecho, Sakyoku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2019 | Year | 02 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of cerebral cortex for individuals with spondylotic cervical myelopathy at within a month of operation and post-operative state at 2-3 months.
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039301
| 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 |
