UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032771 |
|---|---|
| Receipt number | R000037390 |
| Scientific Title | Influence of static magnetic field stimulation on parietal association cortex of healthy subjects on visual cognition function |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2019/07/25 12:49:37 |
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Basic information
Public title
Influence of static magnetic field stimulation on parietal association cortex of healthy subjects on visual cognition function
Acronym
The influence of static magnetic field on visual cognitive function
Scientific Title
Influence of static magnetic field stimulation on parietal association cortex of healthy subjects on visual cognition function
Scientific Title:Acronym
The influence of static magnetic field on visual cognitive function
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the visuospatial cognitive function changes after transcranial static magnetic field stimulation for the right parietal association field
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Line bisection task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Perform static magnetic field stimulation for 15 minutes
Interventions/Control_2
Perform sham stimulation 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adult who was offered to participate in this research by a poster for recruitment of research participants, posted in Hiroshima University Health Science Research Building
* The age at the time of acquiring consent is 20 years old or over, and gender of male and female does not matter.
* Those who were not treated during treatment and those who were considered "abnormal" by medical checkup this spring in the case of students.
2. A person who understands the purpose of this research and obtains consent in writing on participation of this research.
Key exclusion criteria
1. Persons with a history of neurological disorder or merger
2. Persons who have interests such as taking lectures in charge of researchers
3 Other persons who have judged that it is inappropriate for the Research Director or Research Co-Investigator to implement this research
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hikari |
| Middle name | |
| Last name | Kirimoto |
Organization
Graduate School of Biomedical & Health sciences, Hiroshima University
Division name
Department of Sensorimotor Neuroscience
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, Japan
TEL
0822575445
hkirimoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikari |
| Middle name | |
| Last name | Kirimoto |
Organization
Graduate School of Biomedical & Health sciences, Hiroshima University
Division name
Department of Sensorimotor Neuroscience
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, Japan
TEL
0822575445
Homepage URL
hkirimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical & Health sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Graduate School of Biomedical & Health sciences, Hiroshima University
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, Japan
Tel
0822575447
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
| 2018 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000037390
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
16
Results
In visual space cognitive function, it was suggested that tSMS for the right temporal lobe of a healthy subject showing right bias improves the accuracy of the line segmenting task by Tachyscope.
Results date posted
| 2019 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We studied 18 healthy volunteers(10 males and 8 females,21-43 years old) who were not receiving medical treatment for any reason.
Participant flow
All participants provided written, informed consent prior to the experiment, which was conducted in accordance with the principles of the Declaration of Helsinki. The protocol was also approved by the Ethics Committee of Hiroshima University.
Adverse events
Nothing
Outcome measures
The accuracy of tachystoscopically presented line bisection
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2018 | 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
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037390
