UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054711 |
|---|---|
| Receipt number | R000059213 |
| Scientific Title | Brain-spinal cord neural activity using functional Magnetic Resonance Imaging during lower extremity motor execution and Imagery |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/06/19 17:35:03 |
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Basic information
Public title
MRI study of neural activity in the brain and spinal cord
Acronym
Brain and spinal cord fMRI
Scientific Title
Brain-spinal cord neural activity using functional Magnetic Resonance Imaging during lower extremity motor execution and Imagery
Scientific Title:Acronym
Brain and spinal cord fMRI
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to assess neural activity at the brain and spinal cord level during motor execution motor imagery by brain-spinal cord fMRI.
Basic objectives2
Others
Basic objectives -Others
Establishment of a new evaluation method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of fMRI of the brain and spinal cord.
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 |
Interventions/Control_1
Assess neural activity at the brain and spinal cord level during motor execution motor imagery by brain-spinal cord fMRI.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Healthy men and women between the ages of 20-80
(ii) Those who have given consent to the research
Key exclusion criteria
(i) Those who have metal in the head and neck or trunk
(ii) Those who suffer from mental or neurological disorders
(iii) Those who are currently taking psychotropic drugs or other medications that affect neurological functions
(iv) Those who are claustrophobic
(v) Those who are deemed inappropriate by the physician for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Miyazaki |
Organization
National Center of Neurology and Psychiatry, Hospital
Division name
Physical Rehabilitation
Zip code
1878551
Address
Ogawa higashimachi 4-1-1, Kodaira, Tokyo
TEL
0423412711
yuta_miyazaki07@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Miyazaki |
Organization
National Center of Neurology and Psychiatry, Hospital
Division name
Physical Rehabilitation
Zip code
187-8551
Address
Ogawa higashimachi 4-1-1, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
yuta_miyazaki07@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 Center of Neurology and Psychiatry
Address
Ogawa higashimachi 4-1-1, Kodaira, Tokyo
Tel
0423412711
rinri-jimu@ncnp.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 | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059213
