UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014629 |
|---|---|
| Receipt number | 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 13:20:00 |
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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
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
tobi@neurophy.med.kyushu-u.ac.jp
Public contact
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
nakazono@med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
