UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043574 |
|---|---|
| Receipt number | R000049762 |
| Scientific Title | The study on establishment of the appropriate method for recording event-related potentials evoked by stimulating small fiber |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2021/03/10 09:58:16 |
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Basic information
Public title
Establishment of the appropriate method for recording pain-related potentials by intra-epidermal electrical stimulation
Acronym
Establishment of the appropriate method for recording pain-related potentials
Scientific Title
The study on establishment of the appropriate method for recording event-related potentials evoked by stimulating small fiber
Scientific Title:Acronym
The study on establishment of the appropriate method for recording pain-related potentials
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the appropriate method of evaluating somatosensory evoked potentials by intra-epidermal electrical stimulation in two ways; conventional one-point stimulation and multiple-point stimulation
Basic objectives2
Others
Basic objectives -Others
Accuracy and convenience of the methods of the examination
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination time, evoked rate, latency and amplitude of pain-related potential in conventional one-point stimulation and multiple-point stimulation
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Examination of somatosensory-evoked potentials by intra-dermal electrical stimulation in both ways of conventional one-point stimulation and multiple-point stimulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Volunteers recruited from staffs in Chiba university hospital who agree with the content of the present study
Key exclusion criteria
Those who have some neurological disorders or medical diseases with potential neurological complication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwahara |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Neurology
Zip code
260-8670
Address
1-8-1, Inohana, Chuou-ku, Chiba city
TEL
043-226-2129
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kojima |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Neurology
Zip code
260-8670
Address
1-8-1, Inohana, Chuou-ku, Chiba city
TEL
043-226-2129
Homepage URL
ytkjm@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Neurology, Graduate School of Medicine, Chiba 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
Ethics committee in Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuou-ku, Chiba city
Tel
043-226-2496
inohana-rinri@chiba-u.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
| 2021 | Year | 03 | Month | 17 | 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
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 03 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049762
| Research Plan | |
|---|---|
| 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 |
