UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057472 |
|---|---|
| Receipt number | R000065668 |
| Scientific Title | Investigation of Neural Mechanisms in Human Tool Use -Examination Using Eye Gaze and EEG |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/03/31 23:12:10 |
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Basic information
Public title
Investigation of Neural Mechanisms in Human Tool Use -Examination Using Eye Gaze and EEG
Acronym
Investigation of Neural Mechanisms in Human Tool Use
Scientific Title
Investigation of Neural Mechanisms in Human Tool Use -Examination Using Eye Gaze and EEG
Scientific Title:Acronym
Investigation of Neural Mechanisms in Human Tool Use
Region
| Japan |
Condition
Condition
Healthy Adults/Stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the components involved in tool use by means of eye gaze and EEG analysis, leading to a pathological interpretation of tool use disorders after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will measure eye gaze and electroencephalogram (EEG) during tool use to examine eye gaze behavior and brain activity related to tool use. In addition, we will compare the results with those in the control conditions of free viewing the tool and lifting it up.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who have given consent for the study will be included in the study. Post-stroke patients admitted to a convalescent hospital who gave consent for the study will also be included in order to analyze the factors involved in impaired tool use after brain injury. Patients with first stroke will be included if they are able to sit in a chair or wheelchair under supervision.
Key exclusion criteria
Patients with pre-existing cerebrovascular disease, left-handed patients, and those who cannot understand the purpose of the study or perform the tasks due to severe aphasia will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taisuke |
| Middle name | |
| Last name | Ono |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
f2991899@kio.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Ono |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
f2991899@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
f2991899@kio.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 | 03 | Month | 31 | 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 | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Examination of eye gaze and EEG analysis of familiar and unfamiliar tools
Condition.Free gaze condition,Pantomime condition,Lift condition
We will examine the differences in gaze behavior using familiar tools and unfamiliar tools that are considered to require more inference for motor planning and tool use. In order to analyze the brain activity during gaze behavior, we measure the electroencephalogram (EEG) during each condition.
2)Examination of eye gaze, EEG, and kinematic characteristics during tool use
Condition.Actual use condition,Lift condition
Kinematic characteristics during tool operation, gaze behavior when a tool is presented, and brain activity during tool operation are analyzed by EEG measurement.
3)Examination of eye gaze and EEG related to the analysis of physical characteristics of tools
Condition.Item-centered localization condition,tool lifting condition
To analyze the processing mechanism in predicting the physical characteristics of tools (estimation of the center of gravity), a task to estimate the center of the object and a task to lift the object after estimating the center of gravity of the object are performed. Gaze behavior and electroencephalograms will be measured during the task.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065668
