UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061581 |
|---|---|
| Receipt number | R000070453 |
| Scientific Title | Elucidating Capacity-Dependent Prefrontal Cortex Activity During Cognitive-Motor Dual-Task Interference |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/05/14 22:05:44 |
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Basic information
Public title
Elucidating Capacity-Dependent Prefrontal Cortex Activity During Cognitive-Motor Dual-Task Interference
Acronym
Elucidating Prefrontal Cortex Activity During Dual-Task Interference
Scientific Title
Elucidating Capacity-Dependent Prefrontal Cortex Activity During Cognitive-Motor Dual-Task Interference
Scientific Title:Acronym
Elucidating Prefrontal Cortex Activity During Dual-Task Interference
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between prefrontal cortex activity and dual-task interference during cognitive-motor dual-tasking.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. PASAT accuracy (cognitive task performance)
2. Deviation distance in the spiral drawing task (motor task performance)
3. Theta-band power in the prefrontal and parietal regions (neural activity measures)
Key secondary outcomes
1. Functional connectivity of Frontoparietal network (wavelet coherence)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
A cognitive-motor dual-task consisting of the Paced Auditory Serial Addition Test (PASAT) and a spiral drawing task will be performed, and electroencephalography (EEG; 32 channels, international 10-20 system) will be recorded under multiple conditions in which the interstimulus interval (ISI) is manipulated.
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. Right-handed healthy adults
2. No history of psychiatric or neurological disorders
3. A person who signed written informed consent
Key exclusion criteria
Individuals with visual, auditory, or cognitive impairments that may affect task performance.
Target sample size
36
Research contact person
Name of lead principal investigator
| 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
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Faculty of Health Sciences at 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
| 2026 | Year | 06 | Month | 30 | 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
| 2026 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070453
