UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	High resolution MR neuro-imaging for compressive myelopathy patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masao Koda
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedic Surgery
Address	1-8-1 Inohana, Chuo-Ku, Chiba
TEL	043-226-2961
Email	masaokod@gmail.com

Public contact
Name of contact person	Asako Kono
Organization	Chiba University Hospital
Division name	Crlinical Research Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016290