UMIN-CTR Clinical Trial

Basic information
Public title	Influence of brain activation by transcranial direct current electrical stimulation on sensation of the hand
Acronym	Influence of hand sensation by transcranial direct current electrical stimulation
Scientific Title	Influence of brain activation by transcranial direct current electrical stimulation on sensation of the hand
Scientific Title:Acronym	Influence of hand sensation by transcranial direct current electrical stimulation
Region	Japan

Condition
Condition	There are no target diseases
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is for healthy subjects to investigate whether tDCS affects the sense of the hand and what impact it will have if it affects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The current perception threshold and the pain corresponding current value obtained by PainVision before and after electrical stimulation are compared between conditions. Also, the pain index calculated from the current perception threshold and the corresponding current, and the pain level are compared between conditions.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	The primary motor cortex is stimulated by tDCS for 15 minutes. The type of stimulation of tDCS are three types of of anodal stimulation, cathodal stimulation, sham stimulation.
Interventions/Control_2	The primary somatosensory cortex is stimulated by tDCS for 15 minutes. The type of stimulation of tDCS are three types of of anodal stimulation, cathodal stimulation, 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1,Healthy adults aged 20 years or older who had posted on this facility (within the Hiroshima University Kasumi Campus) and had a proposal to participate in this research as a research participant recruitment 2.Person who obtains consent in writing on participation of this research
Key exclusion criteria	1.Persons who have a history / merger of neurological disorder, mental illness 2.Persons with disabilities in cognitive functions 3.Persons who have skin disorder where electrodes can not be attached to fingers 4.Those with interests with researchers and research managers (including those who may be lectured by researchers) 5.Other persons who have judged that it is inappropriate for the Research Director or Research Assignee to implement this research
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Sunagawa
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Laboratory of analysis & control of upper extremity function
Zip code
Address	1-2-3 Kasumi,Minami-ku, Hiroshima
TEL	082-257-5455
Email	torusuna@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akio Ueda
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Laboratory of analysis & control of upper extremity function
Zip code
Address	1-2-3 Kasumi,Minami-ku, Hiroshima
TEL	082-257-5455
Homepage URL
Email	d166430@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Graduate School of Biomedical & Health Sciences
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
Address
Tel
Email

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 07 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	Completed
Date of protocol fixation	2017 Year 06 Month 20 Day
Date of IRB	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 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	2017 Year 06 Month 30 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032073

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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