UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051755 |
|---|---|
| Receipt number | R000058995 |
| Scientific Title | Exploration of the neuronal and physical correlates of the motivative attitude Mae-muki |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2024/03/05 14:18:28 |
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Basic information
Public title
Exploration of the neuronal and physical correlates of the motivative attitude Mae-muki
Acronym
The multi-dimensional measurement of the motivative attitude Mae-muki
Scientific Title
Exploration of the neuronal and physical correlates of the motivative attitude Mae-muki
Scientific Title:Acronym
The multi-dimensional measurement of the motivative attitude Mae-muki
Region
| Japan | North America |
Condition
Condition
Healthy adults and individuals suffering from Parkinson's disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the neuronal and physical correlates of the motivative mindset called Mae-muki by obtaining multi-dimensional (i.e., neuronal and physical) data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The association among the physiological data, physical measures, performances of cognitive and psychological tasks, and behavioral data
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
Diagnosis
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
This study includes MRI and/or PET measurements of about 60 min. This procedure meets a definition of "Interventions".
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants are supposed to satisfy all criteria of each organization.
National Institutes for Quantum and Radiological Science and Technology [Healthy Personel Experiment]
#1. The participants are supposed to have the capacity to understand the protocol of the experiment and the capacity to consent.
#2. The participants should be healthy individuals over 18y. Approximately half of the participants are supposed to be female.
National Institutes for Quantum and Radiological Science and Technology [Parkinson's disease Experiment]
Patient Group:
#1. The individuals with the capacity to understand the protocol of the experiment and the capacity to consent.
#2. The individuals with Parkinson's disease who satisfy the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (1993).
#3. The individuals with Parkinson's disease whose Hoehn and Yahr Scales are three or smaller than three.
#4. The individuals over 18y.
Control Group:
#1. The participants are supposed to have the capacity to understand the protocol of the experiment and the capacity to consent.
#2. The participants should be healthy individuals age- and sex-matched with the Patient Group. The participants should be over 18y.
NTT Communication Science Laboratories
#1. Adult participants are supposed to have the capacity to understand the protocol of the experiment and the capacity to consent. Non-adult individuals are eligible only when their legal representatives provide consent on behalf of them.
#2. The participants should be healthy individuals over 6y.
University of Tsukuba
#1. The participants are supposed to have the capacity to understand the protocol of the experiment and the capacity to consent.
#2. The participants should be students of the University of Tsukuba.
#3. The participants should be healthy individuals over 18y.
#4. The participants are supposed to be insured by Japan Educational Exchanges and Services.
Key exclusion criteria
Each organization defines its criteria.
National Institutes for Quantum and Radiological Science and Technology [Healthy Personel Experiment]
#1. The individual who has a history of mental or neurological diseases
#2. The individual who has a history of severe physical diseases
#3. The individual who is or might be pregnant or is willing to get pregnant currently
#4. The individual who has a pacemaker or other metallic objects such as surgical clips or bolts inside of the body
#5. The individual who has a tattoo
#6. The individual who has claustrophobia
#7. The individual who has no eyesight
#8. The individual who is thought to be unable to follow the experimenter's instruction
#9. The individual who is thought not to be inappropriate to participate in the study
Criteria #3-6 are only for the participants who are scheduled to attend the MRI session.
The participants who are eligible to participate in the MRI session may be scheduled predominantly.
National Institutes for Quantum and Radiological Science and Technology [Parkinson's disease Experiment]
Patient Group:
#1. The individual who has a severe cognitive impairment
#2. The individual who cannot walk without help
#3-9. Same as the criteria #3-9 of National Institutes for Quantum and Radiological Science and Technology [Healthy Personel Experiment]
Control Group:
Same as the criteria #1-9 of National Institutes for Quantum and Radiological Science and Technology [Healthy Personel Experiment]
NTT Communication Science Laboratories and University of Tsukuba
Same as the criteria #1, 2, 7, 8, and 9 of National Institutes for Quantum and Radiological Science and Technology [Healthy Personel Experiment]
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology Institute for Quantum Medical Science
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
0432063251
yamada.makiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hirao |
Organization
National Institutes for Quantum Science and Technology Institute for Quantum Medical Science
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan.
TEL
0432064709
Homepage URL
yamada.makiko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NTT Communication Science Laboratories
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan.
Tel
043-206-4709
helsinki@qst.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
| 2023 | Year | 07 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058995
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