UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037799 |
|---|---|
| Receipt number | R000043105 |
| Scientific Title | A study of systems underlying posture control in brain and mechanisms of breaking the control process |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2022/04/27 12:49:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of systems underlying posture control in brain and mechanisms of breaking the control process
Acronym
A study of systems underlying posture control in brain and mechanisms of breaking the control process
Scientific Title
A study of systems underlying posture control in brain and mechanisms of breaking the control process
Scientific Title:Acronym
A study of systems underlying posture control in brain and mechanisms of breaking the control process
Region
| Japan |
Condition
Condition
Parkinson's disease, healthy adults
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to reveal mechanisms underlying posture control in healthy individuals and patients suffering from Parkinson's disease.
Basic objectives2
Others
Basic objectives -Others
To clarify cognitive functions and physiological indices related to posture changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations among the degree of changing posture and MRI data.
Key secondary outcomes
EEG, performance in cognitive tasks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Comparison between medication and non-medication in patients suffering from Parkinson's disease
Interventions/Control_2
Guiding posture
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient group
1. Patients who meet the MDS criteria for Parkinson's disease
Healthy control
1. A person who has the ability to provide informed consent
2. A person who matches the age with patient as possible
Key exclusion criteria
Patient group
1. A patient who cannot stand for 10min
2. A patient over Hoehn & Yahr Stage three
3. A patient with severe cognitive decline
4. A patient who has had drug abuse or substance dependence during the past year
5. A patient who overtly has had a brain disease (ex. cerebral infarction)
6. A patient who has serious coexisting illness (cardiac insufficiency, renal insufficiency, liver insufficiency, hemorrhagic peptic ulcer, intestinal obstruction, uncontrolled angle-closure glaucoma, cancer)
7. A patient who is pregnant or potentially pregnant
8. A patient who has a pacemaker, metal, or tattoo on his/her body
9. A patient with claustrophobia
10. A patient who is completely blind.
11. A participant who is regarded as ineligible for participation by a researcher /doctor
Healthy control
1. A person who has had psychiatric disorders
2. A person who has had Parkinson's disease or other serious illness
3. A person who is pregnant or potentially pregnant
4. A person who has a pacemaker or metal on his/her body
5. A person who has tattoo on his/her body
6. A person with claustrophobia
7. A person who is completely blind.
8. A person who is regarded as ineligible for participation because of his/her disobedience or lack of understanding by a researcher /doctor
9. A person who is regarded as ineligible for participation by a researcher /doctor
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
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
TEL
043-206-4714
yamada.makiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Tamaki |
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
TEL
043-206-3251
Homepage URL
tamaki.kentaro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
Institute for Quantum Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Scinence
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel
043-206-4706
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
| 2019 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
