UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis and elucidation of small-fiber dysfunction using electrophysiological technique
Title of the study (Brief title)	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	Minori Kodaira
Organization	Shinshu University School of Medicine
Division name	Department of Medicine (Neurology and Rheumatology)
Address	3-1-1 Asahi, Matsumoto
TEL	0263-37-2673
Email	mkodaira@shinshu-u.ac.jp

Public contact
Name of contact person	Minori Kodaira
Organization	Shinshu University School of Medicine
Division name	Department of Medicine (Neurology and Rheumatology)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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