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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043574
Receipt No. 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

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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
Email 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
Email ytkjm@koto.kpu-m.ac.jp

Sponsor
Institute Department of Neurology, Graduate School of Medicine, Chiba University
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 Ethics committee in Graduate School of Medicine, Chiba University
Address 1-8-1, Inohana, Chuou-ku, Chiba city
Tel 043-226-2496
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049762

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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