UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018940 |
|---|---|
| Receipt number | R000021912 |
| Scientific Title | How does the brain generate 3-D? Study using magnetoencephalography and electroencephalography |
| Date of disclosure of the study information | 2015/09/08 |
| Last modified on | 2019/09/26 10:59:43 |
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Basic information
Public title
How does the brain generate 3-D? Study using magnetoencephalography and electroencephalography
Acronym
How does the brain generate 3-D? Study using magnetoencephalography and electroencephalography
Scientific Title
How does the brain generate 3-D? Study using magnetoencephalography and electroencephalography
Scientific Title:Acronym
How does the brain generate 3-D? Study using magnetoencephalography and electroencephalography
Region
| Japan |
Condition
Condition
visually induced motion sickness
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine sensory integrative processes by measuring brain activity during viewing 3D
Basic objectives2
Others
Basic objectives -Others
basic research for understanding neural mechanisms and principles
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity during viewing 3D images (amplitude change of the electromagnetic field caused by 2-second image presentation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Presenting 3D images (approximately 20 minutes)
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects (1) have normal or corrected-to-normal visual acuity and no motor deficit and (2) can understand the research plan and give written consent
Key exclusion criteria
Subjects (1) are not claustrophobia, (2) do not have metals within the body, or (3) are not pregnant
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsudo |
| Middle name | |
| Last name | Hiroyuki |
Organization
Kyushu University
Division name
Faculty of Human-Environment Studies
Zip code
819-0395
Address
744 Moto-oka, Nishi-ku, Fukuoka
TEL
092-802-5171
hmitsudo@lit.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsudo |
| Middle name | |
| Last name | Hiroyuki |
Organization
Kyushu University
Division name
Faculty of Human-Environment Studies
Zip code
819-0395
Address
744 Moto-oka, Nishi-ku, Fukuoka
TEL
092-802-5171
Homepage URL
hmitsudo@lit.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Comittee of Kyushu University Hospital
Address
3-3-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2015 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.visres.2019.08.009
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.visres.2019.08.009
Number of participants that the trial has enrolled
25
Results
Neural responses associated with stereo vision were identified.
Results date posted
| 2019 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult participants
Participant flow
1. Stereo vision test
2. Measurement of brain responses
Adverse events
None
Outcome measures
Brain Responses
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | 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
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021912
