UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect for visual attention by the peripheral electrical stimulation: From the point of view of the subtype in visual attention
Title of the study (Brief title)	The effect for visual attention by the peripheral electrical stimulation
Region	Japan

Condition
Condition	Non
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we investigate whether the perpheral electrical stimulation affected the subtype of visual attention.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lafe /right ratio in passivity attention task evaluating by @attention
Key secondary outcomes	Line bisection task

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Peripheral electrical stimulation
Interventions/Control_2	Sham stimulation
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	healthy adult with right dominant more than 20 age
Key exclusion criteria	1)Participants received the cerebrovascular 2)Participants received the physical and mental disorder (i.e. epileptic seizure) 3)At baseline, participant below the cutoff value of line bisection task
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Takebayashi
Organization	Kibi International university
Division name	Department of Occupational therapy
Address	8, Iga, Takahashi-city, Okayama-preferenec
TEL	0866-22-9454
Email	takshi77@gmail.com

Public contact
Name of contact person	Takashi Takebayashi
Organization	Kibi international university
Division name	Department of occupational therapy
Address	8, Iga, Takahashi-city, Okayama-preferenec
TEL	0866-22-9454
Homepage URL
Email	takshi77@gmail.com

Sponsor
Institute	Kibi international university
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 19 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034791