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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038851
Receipt No. 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

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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
Email 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
Email shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute Faculty of Agriculture, Kyushu University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044303

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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