UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019749 |
|---|---|
| Receipt number | R000022811 |
| Scientific Title | Examination of the reference values of Japanese in nerve conduction study using ultrasound-guided near nerve recording. |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2022/05/21 13:51:05 |
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Basic information
Public title
Examination of the reference values of Japanese in nerve conduction study using ultrasound-guided near nerve recording.
Acronym
Examination of the reference values of Japanese in nerve conduction study using ultrasound-guided near nerve recording.
Scientific Title
Examination of the reference values of Japanese in nerve conduction study using ultrasound-guided near nerve recording.
Scientific Title:Acronym
Examination of the reference values of Japanese in nerve conduction study using ultrasound-guided near nerve recording.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Near nerve recording is the very sensitive method of nerve conduction study, but, this method needs difficult maneuver and has not been available in Japan, However, by using ultrasound guide, near nerve recording can be performed simply and correctly. The aim of this study is to identify the reference values of Japanese in nerve conduction study using near nerve recording by collecting the data in healthy Japanese subjects, with the aid of ultrasound guide.
Basic objectives2
Others
Basic objectives -Others
to identify the reference values of Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Values obtained in the nerve conduction study using ultrasound guided near nerve recording.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Inserting needle electrodes for healthy volunteers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
subjects with neural disease
subjects with bleeding tendency
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Saura |
Organization
Osaka medical and pharmaceutical university
Division name
Department of rehabilitation medicine
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki City, Osaka
TEL
072-683-1221
saura@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Nakano |
Organization
Osaka medical and pharmaceutical university
Division name
Department of rehabilitation medicine
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki City, Osaka
TEL
0726831221
Homepage URL
haruki.nakano@ompu.ac.jp
Sponsor or person
Institute
Department of rehabilitation medicine,Osaka medical and pharmaceutical university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka medical and pharmaceutical university
Address
Takatsuki city
Tel
0726831221
haruki.nakano@ompu.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
| 2015 | Year | 11 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022811
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
