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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004996
Receipt No. R000005940
Scientific Title Threshold for electrical stimuli to the finger tips
Date of disclosure of the study information 2011/02/03
Last modified on 2011/08/02

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Basic information
Public title Threshold for electrical stimuli to the finger tips
Acronym Threshold for electrical stimuli to the finger tips
Scientific Title Threshold for electrical stimuli to the finger tips
Scientific Title:Acronym Threshold for electrical stimuli to the finger tips
Region
Japan

Condition
Condition normal subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To get data for safety guideline for electrical stimuli, we will measure sensory threshold for various kinds of electrical stimulation given to the finger tips in normal subjects.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Mean thresholds for several frequecny sinusoidal electric currents in normal subjects.
Key secondary outcomes Dependency of the threshold on the age, sex or other factors of subjects.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old >=
Gender Male and Female
Key inclusion criteria normal subjets with infromed consent
Key exclusion criteria nothing
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Ugawa
Organization Fukushima Medical University
Division name Department of Neurology
Zip code
Address 1 Hikarigaoka, Fukushima city 960-1295, Japan
TEL 024-547-1246
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Ugawa
Organization Fukushima Medical University
Division name Department of Neurology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization NUS Japan
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
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
2011 Year 02 Month 03 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 Completed
Date of protocol fixation
2011 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 nothing special

Management information
Registered date
2011 Year 02 Month 01 Day
Last modified on
2011 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005940

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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