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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036623
Receipt No. 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 2019/04/29

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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
Email 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
Email suzuki-mak@tokyo-kasei.ac.jp

Sponsor
Institute Faculty of Health Sciences
Institute
Department

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
Email 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 Open public recruiting
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 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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