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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044089
Receipt No. 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 2021/05/06

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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
Email 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
Email hkirimoto@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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