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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008829
Receipt No. 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

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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
Institute Department of Otolaryngology, Faculty of Medicine, University of Tokyo
Institute
Department

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
URL(English) https://upload.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


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