UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044089 |
|---|---|
| Receipt number | R000050349 |
| Scientific Title | The effects of transcranial direct current and static magnetic field stimulation on primary motor cortex on interhemispheric inhibition |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2023/04/04 14:46:52 |
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Basic information
Public title
The effects of transcranial direct current and static magnetic field stimulation on primary motor cortex on interhemispheric inhibition
Acronym
The effects of transcranial direct current and static magnetic field stimulation on primary motor cortex on interhemispheric inhibition
Scientific Title
The effects of transcranial direct current and static magnetic field stimulation on primary motor cortex on interhemispheric inhibition
Scientific Title:Acronym
The effects of transcranial direct current and static magnetic field stimulation on primary motor cortex on interhemispheric inhibition
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to compare the intervention effect of transcranial static magnetic fields stimulation (tSMS) and conventional brain stimulation methods on the primary motor cortex and provide the basic data necessary for clinical application to neurorehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
interhemispheric inhibition: IHI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial static magnetic field stimulation
Interventions/Control_2
Transcranial direct current stimulation
Interventions/Control_3
Sham tSMS
Interventions/Control_4
Sham tDCS
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults who have been offered to participate in this research by the poster for recruiting research participants posted in the Hiroshima University Health Sciences Research Building.
* The age at the time of obtaining consent must be 20 years or older, regardless of gender.
* Those who do not have any disease under treatment.
(2) Those who understand the purpose of this research and can obtain written consent for participation in this research.
Key exclusion criteria
1.Persons with a history or complication of nervous system and circulatory system diseases
2. Those who have metal (cardiac pacemaker, cochlear implant, etc.) in their body
3. Pregnant woman
4. Those who have an interest such as taking a lecture that the researcher is in charge of
5. In addition, those who are judged to be inappropriate for conducting this research by the principal investigator or the research coordinator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hikari |
| Middle name | |
| Last name | Kirimoto |
Organization
Hiroshima University
Division name
Department of Sensorimotor Neuroscience, Graduate School of Biomedical and Health Sciences
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
0822575445
hkirimoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiakari |
| Middle name | |
| Last name | Kirimoto |
Organization
Hiroshima University
Division name
Department of Sensorimotor Neuroscience, Graduate School of Biomedical and Health Sciences
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
0822575445
Homepage URL
hkirimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Hiroshima University
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
Tel
0822575445
hkirimoto@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
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.neuroscience.2023.03.006
Number of participants that the trial has enrolled
17
Results
Our preliminary results revealed that while tSMS over the left and right DLPFC impaired working memory performance to a similar extent, the impacts of tSMS on brain oscillatory responses were different between the left and right DLPFC stimulations. These findings support evidence that the left and right DLPFC play different roles in working memory and suggest that the neural mechanism underlying the impairment of working memory by tSMS can be different between left and right DLPFC stimulations.
Results date posted
| 2023 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050349
| Research Plan | |
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| 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 |
