UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Inducing the plasticity of primary motor area by transcranial alternating current stimulation
Title of the study (Brief title)	Inducing the plasticity of primary motor area by tACS
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of tACS phase and frequency on primary motor area excitability
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor evoked potential amplitudes
Key secondary outcomes	1.The lasting effects after tACS 2.The awareness in the different tACS conditions

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	To investigate the effects of tACS phase (90, 180, 270, 360 deg) in each frequency (10 Hz, 20 Hz) using motor evoked potetial
Interventions/Control_2	To investigate the effects of tACS frequency (5 Hz, 10 Hz, 20 Hz, 40 Hz) at 90 deg phase using motor evoked potential
Interventions/Control_3	To compare the 90 deg phase effects of 10 and 20 Hz tACS with sham stimulation using motor evoked potential
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.Right-handed healthy adults 2.Participants who agree to participate in this study
Key exclusion criteria	1.Participants with history of neurological diseases 2.Participants with implanted metal devices 3.Pregnant women
Target sample size	40

Research contact person
Name of lead principal investigator	Shozo Tobimatsu
Organization	Graduate School of Medical Science, Kyushu University
Division name	Department of Clinical Neurophysiology
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5543
Email	tobi@neurophy.med.kyushu-u.ac.jp

Public contact
Name of contact person	Hisato Nakazono
Organization	Graduate School of Medical Science, Kyushu University
Division name	Department of Clinical Neurophysiology
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5543
Homepage URL
Email	nakazono@med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Science, Kyushu University
Institute
Department

Funding Source
Organization	Grant-in-Aid for JSPS Fellows
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 03 Day
Anticipated trial start date	2014 Year 08 Month 01 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	2014 Year 07 Month 23 Day
Last modified on	2017 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017017