UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028931
Receipt number 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 2023/09/14 13:35:58

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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 Shigenori
Middle name
Last name Kawabata

Organization

Tokyo Medical and Dental University

Division name

Department of Advanced Technology of Medicine

Zip code

113-8519

Address

1-5-45 yushima, bunkyo-Ku, Tokyo

TEL

0358034195

Email

kawabata.orth@tmd.ac.jp


Public contact

Name of contact person

1st name Shigenori
Middle name
Last name Kawabata

Organization

Tokyo Medical and Dental University

Division name

Department of Advanced Technology of Medicine

Zip code

113-8519

Address

1-5-45 yushima, bunkyo-Ku, Tokyo

TEL

0358034195

Homepage URL


Email

kawabata.orth@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

okyo Medical and Dental University

Address

1-5-45 Yushima Bunkyo-ku Tokyo

Tel

03-3813-6111

Email

syomu1.adm@tmd.ac.jp


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

Enrolling by invitation

Date of protocol fixation

2017 Year 08 Month 31 Day

Date of IRB

2017 Year 10 Month 02 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

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

2023 Year 09 Month 14 Day



Link to view the page

Value
https://center6.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