UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036623 |
|---|---|
| Receipt number | R000041723 |
| Scientific Title | Vestibulo-ocular reflex affected by transcranial alternating current stimulation |
| Date of disclosure of the study information | 2019/04/29 |
| Last modified on | 2019/10/28 11:14:58 |
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Basic information
Public title
Vestibulo-ocular reflex affected by transcranial alternating current stimulation
Acronym
Vestibulo-ocular reflex affected by transcranial alternating current stimulation
Scientific Title
Vestibulo-ocular reflex affected by transcranial alternating current stimulation
Scientific Title:Acronym
Vestibulo-ocular reflex affected by transcranial alternating current stimulation
Region
| Japan |
Condition
Condition
Healthy and neurologically intact
adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine whether transcranial alternating current stimulation affects the vestibulo-ocular reflex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Coherence between eye and head rotation movements is recorded before, during, and after transcranial alternating current stimulation.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A square electrode 2 cm on a side was applied at both sides mastoid process of participant. A battery-powered current stimulator delivers 100-640 Hz sinusoidal stimuli for 10 minutes (peak-to-peak amplitude = 0.4 mA). Participants were asked to fixate the dot with their eyes and rotate their head before, during, and after stimulation (1 Hz and 30 rotations).
Interventions/Control_2
A square electrode 2 cm on a side was applied at both sides mastoid process of participant. A battery-powered current stimulator delivers 100-640 Hz sinusoidal stimuli for 1 minutes (peak-to-peak amplitude = 0.4 mA). Participants were asked to fixate the dot with their eyes and rotate their head before, during, and after 10-minutes sham stimulation including 1-minute actual stimulation (1 Hz and 30 rotations).
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are healthy, neurologically intact volunteers. In addition, screening shows that none are at risk for adverse events during transcranial alternating current stimulation.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
suzuki-mak@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
Homepage URL
suzuki-mak@tokyo-kasei.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tokyo Kasei University
Address
2-15-1 Inariyama, Sayama City, Saitama
Tel
0429521621
kanuma-y@tokyo-kasei.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
東京家政大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 29 | 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 | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041723
