UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026535 |
|---|---|
| Receipt number | R000030474 |
| Scientific Title | Open-label, uncontrolled, non-randamized study of healthy subjects on quality control (reproducibility) of nerve conduction study |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2017/03/13 22:15:39 |
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Basic information
Public title
Open-label, uncontrolled, non-randamized study of healthy subjects on quality control (reproducibility) of nerve conduction study
Acronym
Research on quality control of nerve conduction study
Scientific Title
Open-label, uncontrolled, non-randamized study of healthy subjects on quality control (reproducibility) of nerve conduction study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tadashi Kanouchi |
Organization
Tokyo Medical and Dental University
Division name
Clinical laboratory, Medical hospital
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5627
t-kanouchi.nuro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Kanouchi |
Organization
Tokyo Medical and Dental University
Division name
Clinical laboratory, Medical hospital
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5627
Homepage URL
t-kanouchi.nuro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 | 03 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030474
