UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035396 |
|---|---|
| Receipt number | R000040332 |
| Scientific Title | Investigation of voluntary motor function by artificial neural connection |
| Date of disclosure of the study information | 2018/12/28 |
| Last modified on | 2026/07/29 11:50:06 |
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Basic information
Public title
Discovery of central nervous system function using artificial neural connection
Acronym
Investigation of voluntary motor function by artificial neural connection
Scientific Title
Investigation of voluntary motor function by artificial neural connection
Scientific Title:Acronym
Investigation of voluntary motor function by artificial neural connection
Region
| Japan |
Condition
Condition
Intact adults
Spinal cord injury
Stroke
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate voluntary motor function and central nervous system using spinal magnetic stimulation controlled by artificial neural connections
Basic objectives2
Others
Basic objectives -Others
This study is a basic neurophysiological research project aimed at investigating the mechanisms of voluntary motor control. Its objective is to measure the response to non-invasive percutaneous spinal cord stimulation using kinematics and biosignals, and to investigate the operating mechanisms of the voluntary motor control system, including the spinal neural circuits. The findings will serve as foundational data for a mechanistic understanding of motor control mechanisms, but the primary objective is not to evaluate the effectiveness or safety of therapeutic interventions based on the stimulation itself.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Locomotor function
Voluntary motor function
Autonomic nervous function
Neuroimaging
Electromyography
Urinary function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Transvertebral magnetic stimulation via artificial neural connection in able-bodied individuals
Interventions/Control_2
Transvertebral magnetic stimulation via artificial neural connection in individuals with spinal cord injury
Interventions/Control_3
Transvertebral magnetic stimulation via artificial neural connection in individuals with stroke
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
Able-bodied individuals
Individuals with spinal cord injury
Individuals with stroke
Key exclusion criteria
History of seizure or epilepsy
Pacemaker, brain surgery clip, medical pump, un-titanium metal implants
Pregnancy
Uncontrolled medical conditions
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nishimura |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6834-2375
nppj@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Tazoe |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6379-8411
Homepage URL
nppj@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
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
Tokyo Metropolitan Institute of Medical Science Institutional Review Board
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo
Tel
03-6834-2391
hito-rinri@igakuken.or.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
| 2018 | Year | 12 | Month | 28 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2029 | 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
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040332
