UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056229 |
|---|---|
| Receipt number | R000064245 |
| Scientific Title | The effects of noisy galvanic vestibular stimulation (nGVS) on postural stability |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/10/29 14:59:41 |
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Basic information
Public title
The effects of noisy galvanic vestibular stimulation (nGVS) on postural stability
Acronym
The effects of noisy galvanic vestibular stimulation (nGVS) on postural stability
Scientific Title
The effects of noisy galvanic vestibular stimulation (nGVS) on postural stability
Scientific Title:Acronym
The effects of noisy galvanic vestibular stimulation (nGVS) on postural stability
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of nGVS stimulus parameters on postural stability on a soft floor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The center of pressure(COP) sway area
Key secondary outcomes
The center of pressure(COP) sway path length
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
nGVS at stimulation frequency of 0~30 Hz
Interventions/Control_2
nGVS at stimulation frequency of 0~100 Hz
Interventions/Control_3
nGVS at stimulation frequency of 100~640 Hz
Interventions/Control_4
sham stimulation
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults
2.Participants who agree to participate in this study
Key exclusion criteria
1. Participants with perception of nGVS
2. Participants with a history of neurological or psychiatric disorders
3. Participants with implanted metal devices
4. Pregnant women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Aoi |
| Middle name | |
| Last name | Kusano |
Organization
International University of Health and Welfare Graduate School
Division name
Department of Physical Therapy, Faculty of Medical Science
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-407-0434
24s1166@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Kusano |
Organization
International University of Health and Welfare Graduate School
Division name
Department of Physical Therapy, Faculty of Medical Science
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
092-407-0434
Homepage URL
24s1166@g.iuhw.ac.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Graduate School
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
International University of Health and Welfare Graduate School ethics review committee
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
Tel
092-407-0434
24s1166@g.iuhw.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
| 2024 | Year | 11 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064245
