UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061615 |
|---|---|
| Receipt number | R000070492 |
| Scientific Title | The Effect of Individual Variations in Current Direction Within the Primary Somatosensory Cortex on Tactile Function Induced by tDCS |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 14:21:27 |
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Basic information
Public title
The Effect of Individual Variations in Current Direction Within the Primary Somatosensory Cortex on Tactile Function Induced by tDCS
Acronym
A Study on Individual Differences in the Effects of Weak Electrical Stimulation of the Brain on Tactile Function
Scientific Title
The Effect of Individual Variations in Current Direction Within the Primary Somatosensory Cortex on Tactile Function Induced by tDCS
Scientific Title:Acronym
The Effect of tDCS Current Direction on Tactile Function
Region
| Japan |
Condition
Condition
Central nervous system disorders
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will use individual MRI scans and electric field simulations to evaluate the direction of the electric field vectors generated within each subject's S1 when tDCS is applied to S1 using a fixed electrode configuration. Furthermore, by clarifying the relationship between the direction of the current applied to S1 and changes in tactile function and somatosensory evoked potentials (SEP), we aim to elucidate the neurophysiological factors underlying individual differences in the effects of tDCS stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grating orientation task(Measured before and after the tDCS intervention)
Key secondary outcomes
Somatosensory Evoked Potential
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
Transcranial Direct Current Stimulation
Stimulation duration: 20 minutes; stimulation intensity: 2 mA; fade-in/fade-out: 15 seconds each; electrode size: 5 x 5 cm
Conventional electrode placement conditions
Interventions/Control_2
Transcranial Direct Current Stimulation
Stimulation duration: 20 minutes; stimulation intensity: 2 mA; fade-in/fade-out: 15 seconds each; electrode size: 5 x 5 cm
Current applied perpendicular to the gyri
Interventions/Control_3
Transcranial Direct Current Stimulation
Stimulation duration: 20 minutes; stimulation intensity: 2 mA; fade-in/fade-out: 15 seconds each; electrode size: 5 x 5 cm
Condition: Current parallel to the gyri
Interventions/Control_4
Transcranial Direct Current Stimulation
Stimulation duration: first 30 seconds; stimulation intensity: 2 mA; fade-in and fade-out: 15 seconds each; electrode size: 5 x 5 cm
Sham condition
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were right-handed, healthy adults aged 18 to 30 who were eligible for MRI and tDCS, had received a thorough explanation of the study, and had provided written informed consent.
Key exclusion criteria
Exclusion criteria included individuals with a history of neurological or psychiatric disorders, those with sensory impairments or upper limb dysfunction, those with contraindications for MRI or tDCS, those taking medications that affect neural excitability, and those deemed unable to complete the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Sciences, Doctoral Program
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4455
hwd26011@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Sciences, Doctoral Program
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
hwd26011@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Sekine Yusuke
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
Tel
0252574455
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 | 05 | Month | 18 | 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 | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070492
