UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046181 |
|---|---|
| Receipt number | R000045164 |
| Scientific Title | The effect of high-frequency electrical stimulation for femoral nerve on spinal heteronymous pathways |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2025/03/12 12:21:36 |
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Basic information
Public title
The effect of high-frequency electrical stimulation for femoral nerve on spinal pathways
Acronym
The effect of femoral nerve electrical stimulation on spinal pathways
Scientific Title
The effect of high-frequency electrical stimulation for femoral nerve on spinal heteronymous pathways
Scientific Title:Acronym
The effects of femoral nerve electrical stimulation on heteronymous pathways
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of high-frequency electrical stimulation on spinal heteronymous pathways
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heteronymous facilitation, inhibition
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-frequency electrical stimulation
Interventions/Control_2
Low-frequency electrical stimulation
Interventions/Control_3
Tendon vibration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
History of neurological or orthopedic disease in the lower limb
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
y.takahashi.jk@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
y.takahashi.jk@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Juntendo University, Faculty oh Health Science
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
y.takahashi.jk@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20-008
Org. issuing International ID_1
Juntendo University, Faculty oh Health Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045164
