UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054791 |
|---|---|
| Receipt number | R000062614 |
| Scientific Title | Effects of phase of transcranial Alternating Current stimulation on the cerebellar-vestibular network: a GVS-H study. |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/06/26 21:54:41 |
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Basic information
Public title
Effects of phase of transcranial Alternating Current stimulation on the cerebellar-vestibular network: a GVS-H study.
Acronym
Effects of phase of transcranial Alternating Current stimulation on the cerebellar-vestibular network: a GVS-H study.
Scientific Title
Effects of phase of transcranial Alternating Current stimulation on the cerebellar-vestibular network: a GVS-H study.
Scientific Title:Acronym
Effects of phase of transcranial Alternating Current stimulation on the cerebellar-vestibular network: a GVS-H study.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to examine the modulation of the excitability of the lateral vestibulospinal tract by the phase of cereballar tACS.Hereby, we aim to clarify the cerebellar and vestibular network.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GVS-H
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cerebellar Transcranial Alternating Current Stimulation (Phase of 90 degrees)
Interventions/Control_2
Cerebellar Transcranial Alternating Current Stimulation (Phase of 270 degrees)
Interventions/Control_3
Sham Stimulation
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
Healthy adults
Participants who agree to participate in this study
Key exclusion criteria
Participants with a history of neurological or psychiatric disorders
Participants with implanted metal devices
Pregnant women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osuke |
| Middle name | |
| Last name | Shibata |
Organization
International university of health and welfare graduate school
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
070-2388-6217
23s1084@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Osuke |
| Middle name | |
| Last name | Shibata |
Organization
International university of health and welfare graduate school
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
814-0001
Address
2-4-16 Momochihama, Sawaraku, Fukuoka, Japan
TEL
070-2388-6217
Homepage URL
23s1084@g.iuhw.ac.jp
Sponsor or person
Institute
International university of health and welfare graduate school
Institute
Department
Personal name
Osuke Shibata
Funding Source
Organization
Nothing
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
182-2 Enokizu, Okawa, Fukuoka, Japan
Tel
0944-89-2031
q-rinri@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 | 06 | Month | 26 | 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
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062614
