UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058196 |
|---|---|
| Receipt number | R000066530 |
| Scientific Title | The neural substrate of cortical oscillation induced by binaural beat |
| Date of disclosure of the study information | 2025/08/10 |
| Last modified on | 2025/06/16 17:36:58 |
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Basic information
Public title
The neural substrate of cortical oscillation induced by binaural beat
Acronym
osccilation by binaural beat
Scientific Title
The neural substrate of cortical oscillation induced by binaural beat
Scientific Title:Acronym
osccilation by binaural beat
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the neural basis of cortical synchronisation through binaural beats and also the characteristics of cortical responses to binaural beats. Whether binaural beats elicit different responses compared to simple monaural beat sounds has not been sufficiently investigated. By focusing on this point, detecting binaural beat-specific responses, and further elucidating cortical synchronisation phenomena, this study aims to contribute to advances in neuroscience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trajectory length of center of pressure
Key secondary outcomes
Rrajectory length of anterior-posterior/left-right direction
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
binaural beat/monaural beat
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1] Healthy adults between 18 and 64 years old
[2] Adults who can obtain informed consent
Key exclusion criteria
[1] No history of ongoing treatment for neurological/psychiatric disorders
[2] No musculoskeletal disorders
[3] No internal disorders such as cancer or chronic hepatitis that may affect brain function
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
Department of Pharmacy, School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
ogata_k@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
Department of Pharmacy, School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
Homepage URL
ogata_k@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
International University of Health and Welfare
Address
Enokizu 137-1, Okawa, Fukuoka
Tel
0944-89-2000
ogata_k@iuhw.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
| 2025 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066530
