UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042022