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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019749
Receipt No. 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 2017/01/23

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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
Middle name
Last name Ryuichi Saura
Organization Osaka Medical College
Division name Department of rehabilitation medicine
Zip code
Address 2-7 Daigakumachi Takatsuki City, Osaka
TEL 072-683-1221
Email saura@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruki Nakano
Organization Osaka Medical College
Division name Department of rehabilitation medicine
Zip code
Address 2-7 Daigakumachi Takatsuki City, Osaka
TEL 072-683-1221
Homepage URL
Email hnakano@rio.odn.ne.jp

Sponsor
Institute Department of rehabilitation medicine,Osaka Medical College
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
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
2017 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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