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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011425
Receipt No. R000013377
Scientific Title Investigation on peripheral neuropathy evaluation using a novel vibration device
Date of disclosure of the study information 2013/08/08
Last modified on 2013/08/08

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Basic information
Public title Investigation on peripheral neuropathy evaluation using a novel vibration device
Acronym Neuropathy evaluation study using a novel vibration device
Scientific Title Investigation on peripheral neuropathy evaluation using a novel vibration device
Scientific Title:Acronym Neuropathy evaluation study using a novel vibration device
Region
Japan

Condition
Condition peripheral neuropathy
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the efficacy of novel vibration device to evaluate peripheral neuropathy in earlier stage, more conveniently and non-invasively than conventional method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison with conventional peripheral neuropathy outcome measures
Key secondary outcomes 1) Correlation between vibration thresholds and disease duration of neuropathy symptoms

2) To estimate time to neuropathy manifestations onset form neuropathy signs

3) To investigate whether laboratory data such as HbA1c, uric acid level, blood pressure, BMI and urinalysis correlate with onset of peripheral neuropathy

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who understand the points of this study and give informed-consent in literature.
Key exclusion criteria 1)Subjects who have severe medical illness such as cerebrovascular disorder, cardiovascular disorder, respiratory dysfunction, hepatic disorder, renal disorder or malignancy

2) Subjects who have poor responsibility to consent to participate in this study due to mental disorder such as delirium or depression

3) Subjects inadequate for the study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yu Nakamura
Organization Kagawa University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Kagawa University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 08 Month 08 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison with conventional peripheral neuropathy outcome measures

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013377

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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