UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059064 |
|---|---|
| Receipt number | R000067562 |
| Scientific Title | Neural Mechanisms Underlying Upper Limb Motor-Cognitive Dual-Task Interference |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/09/11 22:34:36 |
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Basic information
Public title
Neural Mechanisms Underlying UpperL imb Motor-Cognitive Dual-Task Interference
Acronym
Neural Mechanisms Underlying Upper Limb Motor-Cognitive Dual-Task Interference
Scientific Title
Neural Mechanisms Underlying Upper Limb Motor-Cognitive Dual-Task Interference
Scientific Title:Acronym
Neural Mechanisms Underlying Upper Limb Motor-Cognitive Dual-Task Interference
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the underlying neural mechanism of dual-task interference.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1. Changes in regional brain activity and functional connectivity
Key secondary outcomes
1. Task performance on single motor tasks, single cognitive tasks, and dual tasks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Brain activity during each condition
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
| 65 | years-old | <= |
Age-upper limit
| 80 | 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 a written informed consent
Key exclusion criteria
1. Neurological findings that interfere with the performance of tasks
2. History of developmental disabilities or psychiatric disorders
3. MRI examinations are contraindicated for individuals with magnetic materials or implanted medical devices in their bodies, as well as those with claustrophobia.
Target sample size
50
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
Japan
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
011-706-3316
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 | 15 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067562
