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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014629
Receipt No. R000017017
Scientific Title Inducing the plasticity of primary motor area by transcranial alternating current stimulation
Date of disclosure of the study information 2014/08/01
Last modified on 2017/07/26

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Basic information
Public title Inducing the plasticity of primary motor area by transcranial alternating current stimulation
Acronym Inducing the plasticity of primary motor area by tACS
Scientific Title Inducing the plasticity of primary motor area by transcranial alternating current stimulation
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Shozo Tobimatsu
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Clinical Neurophysiology
Zip code
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
1st name of contact person
1st name
Middle name
Last name Hisato Nakazono
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Clinical Neurophysiology
Zip code
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)

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 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

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
2014 Year 06 Month 03 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017017

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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