UMIN-CTR Clinical Trial

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

Healthy Adult

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Line bisection task

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Graduate School of Biomedical & Health sciences, Hiroshima University

Institute

Department

Personal name

Organization

JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

30

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000037390

Publication of results

Unpublished

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

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 related 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