UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038851 |
|---|---|
| Receipt number | R000044303 |
| Scientific Title | Enhancement of processing speed and accuracy of visual detection by GABA aspiration in the human brain |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2019/12/11 15:29:56 |
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Basic information
Public title
Enhancement of processing speed and accuracy of visual detection by GABA aspiration
Acronym
The clinical trial of GABA aspiration
Scientific Title
Enhancement of processing speed and accuracy of visual detection by GABA aspiration in the human brain
Scientific Title:Acronym
The clinical trial of GABA aspiration
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of GABA aspiration on enhancement of processing speed and accuracy of visual detection by GABA aspiration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of event-related potentials
Key secondary outcomes
The reaction times and the accuracies by using oddball tasks.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Aspirating 0.5 % GABA vapor diluted by propylene glycol for 7 times (1 aspiration /2 sec).
Interventions/Control_2
Aspirating 0.5 % caffeine vapor diluted by propylene glycol for 7 times (1 aspiration /2 sec).
Interventions/Control_3
Aspirating volatilized propylene glycol for 7 times (1 aspiration /2 sec).
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
| 21 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Persons who is generally regarded as healthy
(2) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria
(1) Persons who have been treated their illness or prevention in a clinic at the time of their informed consent
(2) Persons who will not be judged suitable to the participants by the investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fkuoka-shi, Fukuoka, Japan
TEL
092-802-4673
shimizu@agr.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and forest Products Science
Zip code
819-0395
Address
744 Motooka, Nishi-ku,Fkuoka-shi, Fkuoka, Japan
TEL
092-802-4673
Homepage URL
shimizu@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Humanity-Oriented Science and Engineering, Kindai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Kindai University Faculty of Humanity-Oriented Science and Engineering Ethics Committee
Address
11-6 Kayanomori, Iiduka, Fukuoka, Japan
Tel
0948-22-5655
ohnuki@fuk.kindai.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 | 12 | Month | 11 | 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
15
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 | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 25 | 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 | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044303
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
