UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transcranial alternating current stimulation and error information modulate the motor cortex-evoked activity and behavior
Title of the study (Brief title)	Transcranial alternating current stimulation modulates motor cortex and behavior
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 was to determine whether application of 20-Hz transcranial alternating current stimulation to the premotor cortex modifies the excitability of the primary motor cortex and behavior.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor-evoked potentials of the first dorsal interosseous muscle are recorded before, during, and after transcranial alternating current stimulation. In addition, joint angular velocities and acceleration are also recorded during transcranial alternating current stimulation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Sinusoidal stimulations at 20 Hz for 15,000 cycles (intensity 0.5 mA peak-to-peak amplitude) are delivered. A figure-eight transcranial magnetic stimulation coil is positioned over the motor hand area of the precentral gyrus to stimulate the optimal primary motor cortex site of the first dorsal interosseous muscle. The number of TMS pulses is 120, and the interstimulus interval is random at 5.00-5.05 s (intensity resting motor threshold of 120%).
Interventions/Control_2
Interventions/Control_3
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects are healthy, neurologically intact, right-handed volunteers. In addition, screening shows that none are at risk for adverse events during transcranial alternating current stimulation and transcranial magnetic stimulation.
Key exclusion criteria	None
Target sample size	20

Research contact person
Name of lead principal investigator	Makoto Suzuki
Organization	Tokyo Kasei University
Division name	Faculty of Health Sciences
Address	2-15-1 Inariyama, Sayama City, Saitama
TEL	042-955-6074
Email	maksuzu@gmail.com

Public contact
Name of contact person	Makoto Suzuki
Organization	Tokyo Kasei University
Division name	Faculty of Health Sciences
Address	2-15-1 Inariyama, Sayama City, Saitama
TEL	042-955-6074
Homepage URL
Email	maksuzu@gmail.com

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)

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 02 Day
Anticipated trial start date	2017 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 26 Day
Last modified on	2018 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031999