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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013981
Receipt No. 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

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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
Email 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
Email asako-no@office.chiba-u.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016290

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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