UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062246 |
|---|---|
| Receipt number | R000071226 |
| Scientific Title | Elucidating the longitudinal changes in cortical function, structure, and networks during perceptual learning |
| Date of disclosure of the study information | 2026/08/16 |
| Last modified on | 2026/07/15 15:20:19 |
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Basic information
Public title
Elucidating the longitudinal changes in cortical function, structure, and networks during perceptual learning
Acronym
Cortical plasticity and somatosensory function via perceptual learning and tACS
Scientific Title
Elucidating the longitudinal changes in cortical function, structure, and networks during perceptual learning
Scientific Title:Acronym
Cortical plasticity and somatosensory function via perceptual learning and tACS
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how interventions using perceptual learning (repetitive peripheral electrical stimulation) and transcranial alternating current stimulation (tACS) over the TPJ affect neurotransmitter (e.g., GABA) concentration, white matter microstructure, functional networks, EEG activity, and somatosensory function (two-point discrimination) centered on the TPJ.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-point discrimination threshold (index of somatosensory function), assessed before and after each intervention.
Key secondary outcomes
MRI group: neurotransmitter concentration, gray matter volume, white matter microstructure, and resting-state functional networks. EEG group: resting-state EEG and somatosensory-evoked potentials. All assessed before and after intervention.
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
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Experiment 1: Repetitive peripheral electrical (somatosensory) stimulation at 10-20 Hz to the index fingertip for 20 minutes (active).
Interventions/Control_2
Control: Corresponding sham stimulation for 20 minutes on a separate day.
Interventions/Control_3
Experiment 2: tACS at 10-20 Hz over the TPJ for 20 minutes (active).
Interventions/Control_4
Control: Corresponding sham stimulation for 20 minutes on a separate day.
Interventions/Control_5
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18-35 years who can understand the explanation of the experiment and provide voluntary written informed consent.
Key exclusion criteria
History of neurological disease (e.g., stroke, epilepsy) or psychiatric disease (e.g., depression, schizophrenia); use of drugs affecting the central nervous system; claustrophobia; metal implants in the body; pregnancy; any item applicable on the MRI screening questionnaire; participants who cannot tolerate the minimum required stimulation intensity due to pain or discomfort.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | HIDEAKI |
| Middle name | |
| Last name | ONISHI |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimami, Kita-ku, Niigata-City, 950-3198, Japan
TEL
025-257-4449
onishi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | HIDEAKI |
| Middle name | |
| Last name | ONISHI |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimami, Kita-ku, Niigata-City, 950-3198, Japan
TEL
025-257-4449
Homepage URL
onishi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Hideaki Onishi
Funding Source
Organization
Japan Society for the Promotion of Science (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, Shimami, Kita-ku, Niigata-City, 950-3198, Japan
Tel
025-257-4449
onishi@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
Niigata
Institutions
Institutions
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 16 | 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 | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2029 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071226
