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
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
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
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
