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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034584
Receipt No. R000039423
Scientific Title Effects of vestibular stimulation on subjective visual vertical in healthy subjects
Date of disclosure of the study information 2018/10/21
Last modified on 2018/10/21

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Basic information
Public title Effects of vestibular stimulation on subjective visual vertical in healthy subjects
Acronym Effects of vestibular stimulation on subjective visual vertical in healthy subjects
Scientific Title Effects of vestibular stimulation on subjective visual vertical in healthy subjects
Scientific Title:Acronym Effects of vestibular stimulation on subjective visual vertical in healthy subjects
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To survey how subjective visual vertical of healthy subjects change when they undergo galvanic vestibular stimulation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of subjective visual vertical before the vestibular stimulation and during the stimulation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Right anode galvanic vestibular stimulation will be done for 3minutes by placing the electrode on both side of mastoid process with low amplitude (1.5mA) direct electric current
Interventions/Control_2 Light anode galvanic vestibular stimulation will be done for 3minutes by placing the electrode on both side of mastoid process with low amplitude (1.5mA) direct electric current
Interventions/Control_3 Sham stimulation will be done for 3minutes by placing the electrode on both side of mastoid process with low amplitude (1.5mA) direct electric current
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 Healthy subjects who shows decision by themselves to participate in the study, and who can understand the details and risk of the study by using the instruction and letter of consent
Key exclusion criteria Who has pacemaker or VP-shunt etc. in their body, who cannot sit without handrail, who suffers from neurological disease, who is being treated of otorhinological disease which may be related to the vestibular nerve, who has a experience of epileptic seizure, who is being treated of head injury
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Tomioka
Organization National Hospital Organization Murayama Medical Center
Division name Department of Rehabilitation
Zip code
Address 2-37-1 Gakuen, Musashimurayama City, Tokyo
TEL 042-561-1221
Email ytomi@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Tomioka
Organization National Hospital Organization Murayama Medical Center
Division name Department of Rehabilitation
Zip code
Address 2-37-1 Gakuen, Musashimurayama City, Tokyo
TEL 042-561-1221
Homepage URL
Email ytomi@keio.jp

Sponsor
Institute National Hospital Organization Murayama Medical Center Clinical Research Center
Institute
Department

Funding Source
Organization National Hospital Organization Murayama Medical Center Clinical Research Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Bay Rehabilitation Hospital
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
2018 Year 10 Month 21 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 21 Day
Last modified on
2018 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039423

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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