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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036876
Receipt No. R000042022
Scientific Title Motor cortex excitation and homeostatic plasticity by transcranial alternating current stimulation
Date of disclosure of the study information 2019/05/28
Last modified on 2019/05/28

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Basic information
Public title Motor cortex excitation and homeostatic plasticity by transcranial alternating current stimulation
Acronym Motor cortex excitation and homeostatic plasticity by transcranial alternating current stimulation
Scientific Title Motor cortex excitation and homeostatic plasticity by transcranial alternating current stimulation
Scientific Title:Acronym Motor cortex excitation and homeostatic plasticity by transcranial alternating current stimulation
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to investigate changes in brain activity during transcranial alternating current stimulation.
Basic objectives2 Others
Basic objectives -Others Electroencephalographic oscillations
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Electroencephalographic oscillations are recorded during transcranial alternating current stimulation.
Key secondary outcomes

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 5
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Subjects are seated with their hands and forearms resting on their thighs. Transcranial magnetic stimulation is used to search for the hot spot of the first dorsal interosseous muscle. The electroencephalographic electrodes are attached to nine places centered on the hot spot. A battery-powered current stimulator delivers 5 Hz sinusoidal stimuli for 12 minutes (peak-to-peak amplitude = 0.3 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
Interventions/Control_2 Subjects are seated with their hands and forearms resting on their thighs. Transcranial magnetic stimulation is used to search for the hot spot of the first dorsal interosseous muscle. The electroencephalographic electrodes are attached to nine places centered on the hot spot. A battery-powered current stimulator delivers 10 Hz sinusoidal stimuli for 12 minutes (peak-to-peak amplitude = 0.3 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
Interventions/Control_3 Subjects are seated with their hands and forearms resting on their thighs. Transcranial magnetic stimulation is used to search for the hot spot of the first dorsal interosseous muscle. The electroencephalographic electrodes are attached to nine places centered on the hot spot. A battery-powered current stimulator delivers 20 Hz sinusoidal stimuli for 12 minutes (peak-to-peak amplitude = 0.3 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
Interventions/Control_4 Subjects are seated with their hands and forearms resting on their thighs. Transcranial magnetic stimulation is used to search for the hot spot of the first dorsal interosseous muscle. The electroencephalographic electrodes are attached to nine places centered on the hot spot. A battery-powered current stimulator delivers 40 Hz sinusoidal stimuli for 12 minutes (peak-to-peak amplitude = 0.3 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
Interventions/Control_5 Subjects are seated with their hands and forearms resting on their thighs. Transcranial magnetic stimulation is used to search for the hot spot of the first dorsal interosseous muscle. The electroencephalographic electrodes are attached to nine places centered on the hot spot. A battery-powered current stimulator delivers sham stimuli for 12 minutes (peak-to-peak amplitude = 0 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
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
50 years-old >
Gender Male and Female
Key inclusion criteria The subjects are healthy, neurological intact, right-handed volunteers. In addition, screening shows that none are at risk for adverse events during transcranial magnetic stimulation.
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Suzuki
Organization Tokyo Kasei University
Division name Faculty of Health Sciences
Zip code 350-1398
Address 2-15-1 Inariyama, Sayama City, Saitama
TEL 042-955-6074
Email suzuki-mak@tokyo-kasei.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Suzuki
Organization Tokyo Kasei University
Division name Faculty of Health Sciences
Zip code 350-1398
Address 2-15-1 Inariyama, Sayama City, Saitama
TEL 042-955-6074
Homepage URL
Email suzuki-mak@tokyo-kasei.ac.jp

Sponsor
Institute Tokyo Kasei University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Research Ethics Committee of Tokyo Kasei University
Address 2-15-1 Inariyama, Sayama City, Saitama
Tel 042-952-1621
Email kanuma-y@tokyo-kasei.ac.jp

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 東京家政大学(埼玉県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 28 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 Open public recruiting
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2019 Year 05 Month 28 Day
Last follow-up date
2019 Year 12 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
2019 Year 05 Month 28 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042022

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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