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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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