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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035852
Receipt No. 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 2019/02/12

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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
Middle name
Last name Tomohisa Okada
Organization Kyoto University
Division name Human Brain Research Center
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3695
Email tomokada@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Okada
Organization Kyoto University
Division name Human Brain Research Center
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3695
Homepage URL
Email tomokada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
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 pre-operative (2-4 weeks) and post-operative state at 1-2 weeks, 2-3 months and 11-13 months.

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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