UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027045 |
|---|---|
| Receipt number | 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 16:42:56 |
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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
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
mkodaira@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029068
