UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013981 |
|---|---|
| Receipt number | R000016290 |
| Scientific Title | High resolution MR neuro-imaging for compressive myelopathy patients |
| Date of disclosure of the study information | 2014/05/19 |
| Last modified on | 2016/05/17 22:13:57 |
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Basic information
Public title
High resolution MR neuro-imaging for compressive myelopathy patients
Acronym
High resolution MR neuro-imaging for compressive myelopathy patients
Scientific Title
High resolution MR neuro-imaging for compressive myelopathy patients
Scientific Title:Acronym
High resolution MR neuro-imaging for compressive myelopathy patients
Region
| Japan |
Condition
Condition
compressive myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present trial is to evaluate optimal setting of MR spectroscopy and diffusion tensor imaging of spinal cord in compressive myelopathy patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
DTI: apparent diffusion coefficient value of spinal cord
MRS:neural metabolites of spinal cord
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Comperssive myelopathy patients.
2. Age at 20-85.
3. Patients who are well-informed and agree with participation to the present trial.
Key exclusion criteria
1. Pacemaker
2. Implantation of metal device
3. claustrophobia
4. consciousness disorder
5. Neurological disorders which potentially affect the evaluation of patient's neurological status
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Koda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
043-226-2961
masaokod@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Kono |
Organization
Chiba University Hospital
Division name
Crlinical Research Center
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
043-222-7171
Homepage URL
asako-no@office.chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of the present trial is to evaluate optimal setting of MR spectroscopy and diffusion tensor imaging of spinal cord in compressive myelopathy patients. We will obtain following parameters; (DTI) apparent diffusion coefficient and fractional anisotropy values of spinal cord, (MRS) neural metabolites of spinal cord.
Management information
Registered date
| 2014 | Year | 05 | Month | 17 | Day |
Last modified on
| 2016 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016290
