UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open-label, uncontrolled, non-randamized study of healthy subjects on quality control (reproducibility) of nerve conduction study
Title of the study (Brief title)	Research on quality control of nerve conduction study
Region	Japan

Condition
Condition	none
Classification by specialty	Laboratory medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to improve the intertrial reproducibility of measurements in nerve conduction studies performed by more than two examiners.
Basic objectives2	Others
Basic objectives -Others	Reproducibility
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intertrial reproducibility of measurements (Relative intertrial variation)
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	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Transdermal electrical stimulation to peripheral nerves with the electromyography machine. About 30-50 stimuli per 1 trial. 10-20 trials will be done in 1 month.
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 medical stuffs doing nerve conduction study as medical practice to the patients in our hospital.
Key exclusion criteria	No exclusion criteria
Target sample size	6

Research contact person
Name of lead principal investigator	Tadashi Kanouchi
Organization	Tokyo Medical and Dental University
Division name	Clinical laboratory, Medical hospital
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	+81-3-5803-5627
Email	t-kanouchi.nuro@tmd.ac.jp

Public contact
Name of contact person	Tadashi Kanouchi
Organization	Tokyo Medical and Dental University
Division name	Clinical laboratory, Medical hospital
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	+81-3-5803-5627
Homepage URL
Email	t-kanouchi.nuro@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 29 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 13 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 13 Day
Last modified on	2017 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030474