UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036806 |
|---|---|
| Receipt number | R000041881 |
| Scientific Title | Elucidation of neural basis underlying individual difference in spatial orientation |
| Date of disclosure of the study information | 2019/05/25 |
| Last modified on | 2021/02/17 11:28:47 |
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Basic information
Public title
Elucidation of neural basis underlying individual difference in spatial orientation
Acronym
Neural basis underlying spatial orientation
Scientific Title
Elucidation of neural basis underlying individual difference in spatial orientation
Scientific Title:Acronym
Neural basis underlying spatial orientation
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the neural basis involved in the individual difference in spatial orientation
Basic objectives2
Others
Basic objectives -Others
To assess the effect of visual background on the spatial orientation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Subjective visual vertical (SVV)
Subjective visual body axis (SVBA)
Key secondary outcomes
MRI image (T1 and T2)
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Head MRI (T1 and T2)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals without a neurological or psychiatric history
2. Right handedness
3. Capability of informed consent based on their own decision
Key exclusion criteria
1. Individuals with a history of head trauma
2. Individuals with a history of organic brain and spinal disease
3. Individuals with a history or organic vestibular disease
4. Individuals who have a history of disorders of consciousness and/or seizure
5. Individuals with dizziness and strong motion sickness
6. Individuals who are unable to undergo MRI
7. Individuals that researchers decide that they are inappropriate for study participation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Psychology
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
053-453-2387
tanakas@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Psychology
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
053-453-2387
Homepage URL
tanakas@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School od Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medichine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
Tel
0534532850
quality@hama-med.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
| 2019 | Year | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041881
