UMIN-CTR Clinical Trial

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
Institute	Kansai Medical 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)

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050162