UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054265 |
|---|---|
| Receipt number | R000061965 |
| Scientific Title | Effects of brain functional networks of executive function on gait in healthy older adults. |
| Date of disclosure of the study information | 2024/04/26 |
| Last modified on | 2024/04/26 11:05:14 |
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Basic information
Public title
Effects of brain functional networks of executive function on gait in healthy older adults.
Acronym
BFN-HOLD
Scientific Title
Effects of brain functional networks of executive function on gait in healthy older adults.
Scientific Title:Acronym
BFN-HOLD
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will investigate brain function and anatomical networks during executive function tasks by 3T MRI in healthy subjects (aged 18 to 80 years), as well as walking speed under a dual task, and compare them with those of healthy mature subjects. These results will clarify the role of functional brain networks in executive function during walking and changes with age.
Basic objectives2
Others
Basic objectives -Others
To clarify relationship between the walking and cognitive function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Research will be conducted by requesting research subjects to answer a questionnaire (exercise items). The questions in the questionnaire are related to the exercise items, and the information to be obtained is as follows. The time required to answer the questions is about 10 minutes.
(1) Basic information: gender, age, visual acuity, dominant hand, dominant leg.
(2) Questionnaire (exercise items from the basic checklist used in nursing care projects, etc.: Can you climb stairs without leaning against a handrail or wall? Can you stand up from a chair without holding onto anything? Have you fallen in the past year? (Do you have a great deal of anxiety about falling?) (2) The answers to the following questions.
2. The research subjects will be asked to respond to cognitive function tests (Mini Mental State Examination (MMSE) and Trail Making Test (TMT)). The total time required for both tests is about 10 minutes.
3. MRI measurements will be performed on the same subjects. During the MRI measurements, subjects will perform three tasks: an executive function task, a motor task, and a task in which both the executive and motor tasks are performed simultaneously. The executive task will include either the Stroop task or the Flanker task. For the execution task, the task is displayed on a display in the MRI room, and the subject is asked to respond to the task by pressing a button on his/her hand. The exercise task will be a plantar dorsiflexion exercise of the ankle joint.
4. The Time Go Up test (TUG) will be performed as a walking task for the study subjects. The TUG consists of two types of tests: walking only and walking while performing a simple mental arithmetic problem.
These measurements will be made in 2 to 3 hours.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
We use MRI to investigate the brain function and structure. Brain function and anatomical networks during executive function tasks and gait speed under dual tasks is measured.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons whose free and voluntary consent to participate in the research can be obtained in writing from the individual.
Key exclusion criteria
1. Women who are pregnant or may become pregnant
2. Persons suffering from higher brain dysfunction or psychiatric disorders
3. Persons with visual impairment
4. Persons who have difficulty walking
5. Persons with a history of cerebrovascular or cardiovascular disease
6. Persons with metal, equipment, or artificial objects in the body
7. Persons with tattoos
8. Persons with claustrophobia
9. Persons weighing 100 kg or more
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Tsurugizawa |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute (HIIRI)
Zip code
305-8568
Address
1-1-1, Higashi, Tsukuba, Ibaraki
TEL
050-3522-4931
t-tsurugizawa@aist.go.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Tsurugizawa |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute (HIIRI)
Zip code
305-8568
Address
1-1-1, Higashi, Tsukuba, Ibaraki
TEL
05035224931
Homepage URL
t-tsurugizawa@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
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
National Institute of Advanced Industrial Science and Technology (AIST)
Address
1-1-1, Higashi, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.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
| 2024 | Year | 04 | Month | 26 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | 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
No.
Management information
Registered date
| 2024 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061965
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