UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060062 |
|---|---|
| Receipt number | R000068688 |
| Scientific Title | rospective Observational Study of Individuals Undergoing Neuromodulation Training |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 10:02:18 |
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Basic information
Public title
Prospective Observational Study of Patients Receiving Neuromodulation Services
Acronym
rospective Observational Study of Individuals Undergoing Neuromodulation Training
Scientific Title
rospective Observational Study of Individuals Undergoing Neuromodulation Training
Scientific Title:Acronym
Prospective Observational Study of Individuals Undergoing Neuromodulation
Region
| Japan |
Condition
Condition
Chronic Central Nervous System Related Motor Paralysis and Rare Neurological and Neuromuscular Diseases
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will be conducted to evaluate the effects of neuromodulation training on physical function in individuals with chronic central nervous system related motor paralysis and rare neurological or neuromuscular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor and Sensory Function
Key secondary outcomes
Pain
ADL
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Chronic central motor paralysis, including stroke or spinal cord injury, and rare neurological or neuromuscular diseases
2.Patients who are able to provide verbal consent to participate in this study
As this observational study targets individuals who undergo neuromodulation based training, and eligibility for the training itself is determined by age, no additional age criteria are set for participants in this study.
Key exclusion criteria
1.Individuals who have received any form of cell transplantation within the past year
2. Patients with progressive malignant tumors
3. Patients deemed unsuitable for participation by the principal investigator or coinvestigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tsuji |
Organization
Keio University
Division name
School of Medicine, Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633812
hiroki.okawara@keio.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Okawara |
Organization
Keio University
Division name
Department of Orthopedic Surgery, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633812
Homepage URL
hiroki.okawara@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Designated Donation to the Department of Orthopaedic Surgery and Grants-in-Aid for Scientific Research
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
Keio University School of Medicine Ethics Committee
Address
35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3879
med-rinri-jimu@adst.keio.ac.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
| 2025 | Year | 12 | Month | 12 | 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
| 2024 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | 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
This study is a prospective observational study evaluating physical function, activities of daily living (ADL), pain, and other outcomes in individuals undergoing neuromodulation-based training.
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068688
