UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027935 |
|---|---|
| Receipt number | R000031999 |
| Scientific Title | Transcranial alternating current stimulation and error information modulate the motor cortex-evoked activity and behavior |
| Date of disclosure of the study information | 2017/06/27 |
| Last modified on | 2018/06/28 18:43:44 |
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Basic information
Public title
Transcranial alternating current stimulation and error information modulate the motor cortex-evoked activity and behavior
Acronym
Transcranial alternating current stimulation modulates motor cortex and behavior
Scientific Title
Transcranial alternating current stimulation and error information modulate the motor cortex-evoked activity and behavior
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
maksuzu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
Address
2-15-1 Inariyama, Sayama City, Saitama
TEL
042-955-6074
Homepage URL
maksuzu@gmail.com
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 27 | 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
| 2017 | Year | 06 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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