UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036876 |
|---|---|
| Receipt number | 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 | 2022/05/30 13:37:48 |
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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
3
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 five places centered on the hot spot. A battery-powered current stimulator delivers 10 Hz sinusoidal stimuli for 20 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 five places centered on the hot spot. A battery-powered current stimulator delivers 20 Hz sinusoidal stimuli for 20 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 five places centered on the hot spot. A battery-powered current stimulator delivers sham stimuli for 20 minutes (peak-to-peak amplitude = 0 mA). Participants were asked to fixate the dot with their eyes before, during, and after stimulation.
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
| 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
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
suzuki-mak@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
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
kanaij@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
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3425/12/2/195
Number of participants that the trial has enrolled
16
Results
We found that 10 Hz- and 20 Hz-tACS resulted in larger alpha and beta oscillations, respectively, compared with the oscillations observed after sham-tACS. In addition, 10 Hz- and 20 Hz-tACS decreased the amplitudes of conditioned motor evoked potentials and increased alpha and beta activity, respectively.
Results date posted
| 2022 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | 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
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042022
