UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057182 |
|---|---|
| Receipt number | R000064451 |
| Scientific Title | Effects of static magnetic field stimulation on peripheral nerves on A delta and C fibers: A randomized, double-blind, crossover controlled trial |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/03/01 12:59:15 |
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Basic information
Public title
Effects of static magnetic field stimulation on peripheral nerves on A delta and C fibers: A randomized, double-blind, crossover controlled trial
Acronym
Effects of static magnetic field stimulation on peripheral nerves on A delta and C fibers: A randomized, double-blind, crossover controlled trial
Scientific Title
Effects of static magnetic field stimulation on peripheral nerves on A delta and C fibers: A randomized, double-blind, crossover controlled trial
Scientific Title:Acronym
Effects of static magnetic field stimulation on peripheral nerves on A delta and C fibers: A randomized, double-blind, crossover controlled trial
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the intervention method of exposing peripheral nerves to a static magnetic field environment has an inhibitory effect on the central nervous system processing process of nociceptive sensation in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitude and latency of intraepidermal electrical stimulation evoked potentials by A delta and C fiber stimulation before, immediately after stimulation, and 10 minutes after the end of stimulation
Key secondary outcomes
Comparison of NRS and sensory thresholds of A delta and C fiber stimulation before stimulation, immediately after the end of stimulation, and 10 minutes after the end of stimulation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Place an NdFeB permanent magnet over the radial nerve area for 15 minutes.
Interventions/Control_2
Place sham stimulation over the radial nerve area for 15 minutes.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Individuals with a history of or complications from central nervous system, neuromuscular system, and cardiovascular diseases
Those with metal in their bodies
Pregnant woman
Individuals with skin conditions at the site of attachment of surface stimulation electrodes
Those deemed inappropriate by the principal investigator or co-investigator to conduct this research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ota |
Organization
Hiroshima University Hospital
Division name
Anesthesiology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
0822575555
d7231q@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ota |
Organization
Hiroshima University Hospital
Division name
Anesthesiology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5267
Homepage URL
d7231q@hiroshima-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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 | 03 | Month | 01 | 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
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064451
