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
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
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
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
