UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008829
Receipt number R000010372
Scientific Title Effect of noisy galvanic vestibular stimulation on vestibular reflexes
Date of disclosure of the study information 2012/09/01
Last modified on 2021/03/08 14:29:41

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Basic information

Public title

Effect of noisy galvanic vestibular stimulation on vestibular reflexes

Acronym

Effect of noisy galvanic stimulation on vestibular reflexes

Scientific Title

Effect of noisy galvanic vestibular stimulation on vestibular reflexes

Scientific Title:Acronym

Effect of noisy galvanic stimulation on vestibular reflexes

Region

Japan


Condition

Condition

Bilateral peripheral vestibular dysfunction

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of noisy galvanic vestibular stimulation on vestibule-ocular reflex, vestibule-spinal reflex, and vestibular-autonomic reflex.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gain and phase of the rotation test, amplitude of the responses in vestibular evoked myogenic potential, velocity of movement of the center of pressure on the stabilometer, changes of blood pressure on tilt table.

Key secondary outcomes



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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal subjects and patients with bilateral peripheral vestibular dysfunction

Key exclusion criteria

Subjects who have orthopaedic disorders, heart diseases, malignant diseases, who cannot walk by themselves, or who have metallic materials inside their body (e.g. cerebral aneurysm clip, pace maker)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Iwasaki

Organization

University of Tokyo Hospital

Division name

Department of Otolaryngology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

0358008665

Email

iwashin-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yuzaburo
Middle name
Last name Uetake

Organization

University of Tokyo Hospital

Division name

IRB

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3575

Homepage URL


Email

yuetake-tky@umin.ac.jp


Sponsor or person

Institute

Department of Otolaryngology, Faculty of Medicine, University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Department of Otolaryngology, Faculty of Medicine, University of Tokyo

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

University of Tokyo, Faculty of Medicine, IRB committee

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

yuetake-tky@umin.ac.jp


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

2012 Year 09 Month 01 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

2011 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

2016 Year 04 Month 14 Day

Date of closure to data entry

2016 Year 04 Month 14 Day

Date trial data considered complete

2016 Year 04 Month 14 Day

Date analysis concluded

2016 Year 08 Month 31 Day


Other

Other related information

To examine the effect of noisy galvanic vestibular stimulation on vestibulo-ocular reflex, vestibulo-spinal reflex, and vestibulo-autonomic reflex, rotation test, vestibular evoked myogenic potentials, stabilometer, and tilt test are performed in the presence and absence of noisy vestibular galvanic stimulation.


Management information

Registered date

2012 Year 08 Month 31 Day

Last modified on

2021 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name