UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057584 |
|---|---|
| Receipt number | R000065799 |
| Scientific Title | Investigation of the Effects of Noisy Galvanic Vestibular Stimulation and Its Association with Brain Structure and Functional Connectivity |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/11 14:08:22 |
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Basic information
Public title
Investigation of the Effects of Noisy Galvanic Vestibular Stimulation and Its Association with Brain Structure and Functional Connectivity
Acronym
Investigation of the Effects of Noisy Galvanic Vestibular Stimulation and Its Association with Brain Structure and Functional Connectivity
Scientific Title
Investigation of the Effects of Noisy Galvanic Vestibular Stimulation and Its Association with Brain Structure and Functional Connectivity
Scientific Title:Acronym
Investigation of the Effects of Noisy Galvanic Vestibular Stimulation and Its Association with Brain Structure and Functional Connectivity
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the effects of noisy galvanic vestibular stimulation (nGVS) and the associated brain structures and functional connectivity
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of Pressure Sway During One-Legged and Bipedal Stance
Voxel based morphometry
Functional connectivity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
nGVS group
Interventions/Control_2
sham group
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who have seen the e-mail recruiting experimental subjects and who voluntarily wished to participate in the experiment.
Key exclusion criteria
Persons with neurological or mental illness, persons with metal or electronic devices such as pacemakers in the body, persons taking nerve-acting drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirona |
| Middle name | |
| Last name | Takahashi |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hwd24010@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hirona |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hwd24010@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata 950-3198
Tel
025-257-4455
rinri@nuhw.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
| 2025 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065799
