UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011425 |
|---|---|
| Receipt number | 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 16:06:04 |
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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
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
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013377
