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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028931
Receipt No. R000033109
Scientific Title Establishment of diagnostic method of spinal cord function by MagnetoSpinoGraphy(MSG)
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/31

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Basic information
Public title Establishment of diagnostic method of spinal cord function by MagnetoSpinoGraphy(MSG)
Acronym Establishment of diagnostic method of spinal cord function by MagnetoSpinoGraphy(MSG)
Scientific Title Establishment of diagnostic method of spinal cord function by MagnetoSpinoGraphy(MSG)
Scientific Title:Acronym Establishment of diagnostic method of spinal cord function by MagnetoSpinoGraphy(MSG)
Region
Japan

Condition
Condition spinal cord dysfunction
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Diagnosis of spinal cord function using MagnetoSpinoGraphy(MSG)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes We measure the magnetic field of spinal cord after stimulating peripheral nerve and compare with Somatosensory evoked potential. We will prove effectiveness of MagnetoSpinoGraphy (MSG).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We take MRI images of spinal cord at the same time measuring the magnetic field.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Healthy volunteers
No history of neurological disease in the past.(20-80 year old)

2.Patients of spinal cord dysfunction
Key exclusion criteria 1.Minors
2.Dementia
3.The individuals who dont't agree with the research.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawabata Shigenori
Organization Tokyo Medical and Dental University
Division name Department of Advanced Technology of Medicine
Zip code
Address 1-5-45 yushima, bunkyo-Ku, Tokyo
TEL 0358034195
Email kawabata.orth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kawabata Shigenori
Organization Tokyo Medical and Dental University
Division name Department of Advanced Technology of Medicine
Zip code
Address 1-5-45 yushima, bunkyo-Ku, Tokyo
TEL 0358034195
Homepage URL
Email kawabata.orth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization RICOH COMPANY, LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) TDK Corporation

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
2017 Year 09 Month 01 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
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033109

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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