UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043927
Receipt number R000050162
Scientific Title Collection and analysis of basic data for typical neuromuscular diseases for clinical application of magnetoneurography
Date of disclosure of the study information 2021/04/14
Last modified on 2021/04/14 21:59:28

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Basic information

Public title

Development of neuromuscular measurement

Acronym

Development of neuromuscular measurement

Scientific Title

Collection and analysis of basic data for typical neuromuscular diseases for clinical application of magnetoneurography

Scientific Title:Acronym

Collection and analysis of basic data for typical neuromuscular diseases for clinical application of magnetoneurography

Region

Japan


Condition

Condition

Neurological disease, neuromuscular junction disease, muscle disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measure the neuromuscular magnetic field to elucidate the basic physiology of neuromuscular and examine the usefulness of functional diagnosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

By measuring the neuromuscular magnetic field of patients with neuromuscular diseases and accumulating and analyzing cases, we will establish the optimal measurement method and data analysis

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

measurement neuromuscular magnetic field, measurement X ray

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 and muscle disease in the past.(20-80 year old)

2.Patients with neuromuscular diseases
Patients with the following confirmed diagnosis in neurology department.
Neurological disease
Neuromuscular junction disease
Muscle disease

Key exclusion criteria

1.Minors
2.Pregnant or may become pregnant
3.Dementia
4.Those who have a pacemaker
5.Persons who are judged by the principal investigator to be inappropriate as research subjects

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Nakayama

Organization

Kansai Medical University

Division name

Department of Neurology

Zip code

573-1010

Address

2-5-1 shinmachi, hirakatashi, Osaka

TEL

072-804-0101

Email

kmu.magnetomyography@gmail.com


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Nakayama

Organization

Kansai Medical University

Division name

Department of Neurology

Zip code

573-1010

Address

2-5-1 shinmachi, hirakatashi, Osaka

TEL

072-804-0101

Homepage URL


Email

kmu.magnetomyography@gmail.com


Sponsor or person

Institute

Kansai Medical 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)



IRB Contact (For public release)

Organization

Kansai Medical University

Address

2-5-1 shinmachi, hirakatashi, Osaka

Tel

072-804-0101

Email

kmu.magnetomyography@gmail.com


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

2021 Year 04 Month 14 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

2021 Year 04 Month 14 Day

Date of IRB


Anticipated trial start date

2021 Year 04 Month 14 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 14 Day

Last modified on

2021 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name