UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028727 |
|---|---|
| Receipt number | R000032581 |
| Scientific Title | Magnetic recordings of electrophysiological activity in the peripheral nerve |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2025/03/03 19:12:31 |
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Basic information
Public title
Magnetic recordings of electrophysiological activity in the peripheral nerve
Acronym
Magnetic recordings of electrophysiological activity in the peripheral nerve
Scientific Title
Magnetic recordings of electrophysiological activity in the peripheral nerve
Scientific Title:Acronym
Magnetic recordings of electrophysiological activity in the peripheral nerve
Region
| Japan |
Condition
Condition
peripheral nerve disorders
Classification by specialty
| Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To diagnose the peripheral nerve disorders by measurement of the magnetic fields
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To investigate whether or not we can measure the magnetic fields in the peripheral nerve
Key secondary outcomes
The change of magnetic fields of dameged peripheral nerve
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 peripheral nerve 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
| 18 | 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.Orthopedic and neurological disorders
Nerve entrapment disease, thoracic outlet syndrome,thoracic outlet syndrome, motor neuron desease
Key exclusion criteria
1.Minors
2.Dementia
3.The individuals who don't gree with the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Kawabata |
Organization
Institute of Science Tokyo
Division name
Department of Advanced Technology of Medicine
Zip code
1138519
Address
1-5-45 yushima, bunkyo-Ku, Tokyo
TEL
0358034195
kawabata.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Kawabata |
Organization
Institute of Science Tokyo
Division name
Department of Advanced Technology of Medicine
Zip code
1138519
Address
1-5-45 yushima, bunkyo-Ku, Tokyo
TEL
0358034195
Homepage URL
kawabata.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Heavy Industries, 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
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 yushima, bunkyo-Ku, Tokyo
Tel
0358034547
rinri.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 | 08 | Month | 21 | 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 | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032581
