UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048699 |
|---|---|
| Receipt number | R000055487 |
| Scientific Title | Effect of transcranial static magnetic stimulation over leg motor cortical area on cortical excitability |
| Date of disclosure of the study information | 2022/08/20 |
| Last modified on | 2022/08/19 08:28:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of transcranial static magnetic stimulation over leg motor cortical area on cortical excitability
Acronym
Changes of motor cortical excitability by transcranial static magnetic stimulation over leg motor cortical area
Scientific Title
Effect of transcranial static magnetic stimulation over leg motor cortical area on cortical excitability
Scientific Title:Acronym
Changes of motor cortical excitability by transcranial static magnetic stimulation over leg motor cortical area
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 transcranial static magnetic stimulation over leg motor cortical area on cortical excitability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potentials elicited by transcranial magnetic stimulation
Key secondary outcomes
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
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
single transcranial static magnetic stimulation (use a single magnet)
Interventions/Control_2
single sham stimulation
Interventions/Control_3
triple transcranial static magnetic stimulation (use three magnets)
Interventions/Control_4
triple sham stimulation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No history of neurological, psychological, psychiatric, and cardiovascular diseases
Key exclusion criteria
Those who have medical implants
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Aomori University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
030-8505
Address
58-1 Mase, Hamadate, Aomori
TEL
017-765-2067
t_watanabe3@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Aomori University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
030-8505
Address
58-1 Mase, Hamadate, Aomori
TEL
017-765-2067
Homepage URL
t_watanabe3@auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Aomori University of Health and Welfare
Address
58-1 Mase, Hamadate, Aomori
Tel
017-765-2000
rinri2008@auhw.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
| 2022 | Year | 08 | Month | 20 | 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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | 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
| 2022 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055487
