UMIN-CTR Clinical Trial

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 Yohei Middle name Last name Tomioka
Organization	National Hospital Organization Murayama Medical Center
Division name	Department of Rehabilitation
Zip code	2080011
Address	2-37-1 Gakuen, Musashimurayama City, Tokyo
TEL	042-561-1221
Email	ytomi@keio.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Tomioka
Organization	National Hospital Organization Murayama Medical Center
Division name	Department of Rehabilitation
Zip code	2080011
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	National Hospital Organization Murayama Medical Center Clinical Research Center
Address	2-37-1 Gakuen, Musashimurayama City, Tokyo
Tel	042-561-1496
Email	rinken@murayama-crc.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	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	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
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	2022 Year 10 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039423