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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027045
Receipt No. R000029068
Scientific Title Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Date of disclosure of the study information 2017/04/18
Last modified on 2018/11/19

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Basic information
Public title Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Acronym Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Scientific Title Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Scientific Title:Acronym Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Region
Japan

Condition
Condition Familial amyloid polyneuropathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the utility of intraepidermal electrical stimulation as a clinical examination
Basic objectives2 Others
Basic objectives -Others To elucidate small fiber dysfunction of familial amyloid polyneuropathy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of sensory threshold and evoked potentials evaluated by intraepidermal electrical stimulation with sensory thresold assessed by quantitative sensory testing
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Twice examinations using intraepidermal electrical 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
16 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Patients with familial amyloid polyneuropathy and healthy subjects
Key exclusion criteria Patients or healthy subjects with other neuropathy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minori Kodaira
Organization Shinshu University School of Medicine
Division name Department of Medicine (Neurology and Rheumatology)
Zip code
Address 3-1-1 Asahi, Matsumoto
TEL 0263-37-2673
Email mkodaira@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minori Kodaira
Organization Shinshu University School of Medicine
Division name Department of Medicine (Neurology and Rheumatology)
Zip code
Address 3-1-1 Asahi, Matsumoto
TEL 0263-37-2673
Homepage URL
Email mkodaira@shinshu-u.ac.jp

Sponsor
Institute Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine
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
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 信州大学病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Pain detection threshold using intraepidermal electrical stimulation (IES) and cooling detection threshold using quantitative sensory testing (QST) were positively correlated. Amplitude of evoked potentials (EPs) following electrical stimulation using IES was negatively correlated with pain and cooling detection thresholds. Sensory thresholds and amplitude of EPs were deteriorated with length-dependent pattern in patients with familial amyloid polyneuropathy. These results support a notion that IES is a useful clinical tool for evaluating small-fiber dysfunction.
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
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 11 Month 19 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029068

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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