UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061736 |
|---|---|
| Receipt number | R000070624 |
| Scientific Title | Effects of low-frequency transcranial alternating current stimulation on motor learning and brain activity |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/29 15:00:24 |
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Basic information
Public title
Effects of low-frequency weak electrical brain stimulation on motor skill improvement and brain activity
Acronym
Effects of low-frequency brain stimulation on motor learning and brain activity
Scientific Title
Effects of low-frequency transcranial alternating current stimulation on motor learning and brain activity
Scientific Title:Acronym
Effects of low-frequency tACS on motor learning and brain activity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects of low-frequency transcranial alternating current stimulation (tACS) on finger dexterity and reaction performance. In addition, neural mechanisms underlying the effects of brain stimulation will be investigated by assessing changes in brain activity using functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Finger dexterity task performance, reaction task performance, fMRI data, EEG data, and motor evoked potential (MEP) data before and after brain stimulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
M1-tACS group
Interventions/Control_2
Cerebellum-tACS group
Interventions/Control_3
Motor-related areas-tACS group
Interventions/Control_4
DLPFC-tACS group
Interventions/Control_5
sham group
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults, primarily undergraduate and graduate students at our university, who voluntarily expressed their willingness to participate after receiving an explanation of the study from the principal investigator.
Key exclusion criteria
Individuals with neurological or psychiatric disorders
Individuals with metal implants or electronic devices such as pacemakers in the body
Individuals taking neuroactive medications
Individuals with claustrophobia related to fMRI measurements
Pregnant individuals
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Miyaguchi |
Organization
Niigata university of health and welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Japan
TEL
025-257-4695
miyaguchi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Miyaguchi |
Organization
Niigata university of health and welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Japan
TEL
025-257-4695
Homepage URL
miyaguchi@nuhw.ac.jp
Sponsor or person
Institute
Niigata university of health and welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Niigata University of Health and Welfare Research Ethics Committee
Address
1398 Shimami-cho, Kita-ku, Niigata City, Japan
Tel
025-257-4455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070624
