UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058744 |
|---|---|
| Receipt number | R000067169 |
| Scientific Title | Distinguishing social interaction-specific Inter-Brain Synchrony from other non-specific neural synchrony |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/08 17:46:00 |
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Basic information
Public title
Distinguishing social interaction-specific Inter-Brain Synchrony from other non-specific neural synchrony
Acronym
Distinguishing social interaction-specific Inter-Brain Synchrony from other non-specific neural synchrony
Scientific Title
Distinguishing social interaction-specific Inter-Brain Synchrony from other non-specific neural synchrony
Scientific Title:Acronym
Distinguishing social interaction-specific Inter-Brain Synchrony from other non-specific neural synchrony
Region
| Japan |
Condition
Condition
Young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether Inter-Brain Synchrony (IBS) in cooperative behaviour is a social interaction-specific synchrony, after eliminating as far as possible the influence of the three non-specific neural synchronies that can induce IBS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Inter-Brain Synchrony value during cooperative tangram puzzles
(Wavelet Transform Coherence value)
Key secondary outcomes
1. Synchronized value of emotion (Self-Assessment Manikin scale: Valence, Activation)
2. Synchronized value of eye movement (mutual gazing time, gazing rate)
3. Synchronized value of physical behavior (angular velocity of right elbow and wrist joint)
4. Synchronized value of autonomic responses (skin conductance level, skin conductance response, heart rate, heart rate variability)
5. Number of Tangram puzzle assignments completed
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
1. Healthy adults
2. A person who signed informed consent
3. Right-handed
4. Unacquainted dyads (Inclusion of Others in the Self Scale: IOSS < 4)
Key exclusion criteria
1. History of neurological disorders
2. History of psychiatric disorders
3. History of head trauma or organic disease
4. History of psychotropic medication
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
D.sawamura@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
Homepage URL
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Faculty of Health Sciences, Hokkaido University
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
Tel
0117063316
shomu@hs.hokudai.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 | 10 | Month | 01 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Task: 1 set of 7-piece tangram puzzles, work only with the dominant hand
Condition 1) Cooperation task, Condition 2) Single task, Performance) Number of puzzles completed in 120 seconds
Control of non-specific neural synchrony:
Attention-enhanced neural synchrony) Unified task environment between the two conditions, Confirmation of emotional synchrony
Neural entrainment) Different noise exposure for each participant pair, no conversation
Motor-induced neural synchrony) Mutual gazing time and gazing rate were calculated, and Confirmation of synchrony of the right elbow and right hand joints
IBS)Functional near-infrared spectroscopy is used to measure oxygenated hemoglobin concentrations during bilateral prefrontal and right parietotemporal junction tasks, followed by IBS analysis.
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067169
