UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056176 |
|---|---|
| Receipt number | R000064190 |
| Scientific Title | Neurophysiological study of the effects of emotional changes on attention and concentration |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2024/11/18 09:32:28 |
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Basic information
Public title
Neurophysiological study of the effects of emotional changes on attention and concentration
Acronym
the effects of emotional changes on attention and concentration
Scientific Title
Neurophysiological study of the effects of emotional changes on attention and concentration
Scientific Title:Acronym
the effects of emotional changes on attention and concentration
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will clarify how competitive conditions affect brain waves related to attention concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG signals during the task are acquired from 19 points based on the 10-20 method.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are healthy individuals with no abnormalities in the circulatory system (history of high blood pressure, heart disease, etc.), cranial nervous system (history of epilepsy, movement disorders, sleep disorders, etc.), and visual system (corrected visual acuity of 0.5 or less).
Key exclusion criteria
abnormalities in the circulatory system (history of high blood pressure, heart disease, etc.), cranial nervous system (history of epilepsy, movement disorders, sleep disorders, etc.), and visual system (corrected visual acuity of 0.5 or less).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ohgomori |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka, Osaka, Japan
TEL
0724466700
ohgomorit@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Kawase |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Research support section
Zip code
597-0104
Address
158 Mizuma, Kaizuka, Osaka
TEL
072-446-6700
Homepage URL
soumu@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Osaka Kawasaki Rehabilitation University
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
Osaka Kawasaki Rehabilitation University
Address
158 Mizuma, Kaizuka, Osaka
Tel
072-446-6700
ohgomorit@kawasakigakuen.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
| 2024 | Year | 11 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study. Measuring brain waves while performing tasks in a competitive environment.
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064190
