UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051593 |
|---|---|
| Receipt number | R000058867 |
| Scientific Title | Effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal cord excitability |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2024/01/11 09:25:15 |
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Basic information
Public title
Effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal cord excitability
Acronym
Effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal cord excitability
Scientific Title
Effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal cord excitability
Scientific Title:Acronym
Effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal cord excitability
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the effects of transcutaneous static magnetic field stimulation of the spinal cord on spinal excitability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spinal reflex, evoked potentials
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcutaneous static magnetic field stimulation
Interventions/Control_2
sham stimulation
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are interested in this experiment and voluntarily apply to participate.
Key exclusion criteria
Pregnant women, on dialysis, taking neuroleptic drugs, have metal or electronic devices in the body, have epileptic seizures, or have nerve damage.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Hoshi |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-Cho Kita-Ku Niigata-Shi Niigata
TEL
025-257-4455
haruki-hoshi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Hoshi |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-Cho Kita-Ku Niigata-Shi Niigata
TEL
025-257-4455
Homepage URL
haruki-hoshi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
Niigata University of Health and Welfare
Tel
025-257-4455
haruki-hoshi@nuhw.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
| 2023 | Year | 08 | Month | 10 | 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
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058867
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
