UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032771
Receipt No. 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 (Ver. 5)

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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
Email 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
Email hkirimoto@hiroshima-u.ac.jp

Sponsor
Institute Graduate School of Biomedical & Health sciences, Hiroshima University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037390