UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034584 |
|---|---|
| Receipt number | 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 | 2022/10/27 18:53:07 |
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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 | 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
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
ytomi@keio.jp
Sponsor or person
Institute
National Hospital Organization Murayama Medical Center Clinical Research Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
