UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060163 |
|---|---|
| Receipt number | R000068812 |
| Scientific Title | Effects of Preconditioning with Transcranial Alternating Current Stimulation on Mechanical Tactile Stimulation Effects |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 17:20:51 |
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Basic information
Public title
Effects of Preconditioning with Brain Stimulation on Mechanical Tactile Stimulation Effects
Acronym
Effects of Preconditioning with Brain Stimulation on Mechanical Tactile Stimulation Effects
Scientific Title
Effects of Preconditioning with Transcranial Alternating Current Stimulation on Mechanical Tactile Stimulation Effects
Scientific Title:Acronym
Effects of Preconditioning with Transcranial Alternating Current Stimulation on Mechanical Tactile Stimulation Effects
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of transcranial alternating current stimulation preconditioning on the somatosensory enhancement produced by mechanical tactile stimulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG data
Two-point discrimination data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial Alternating Current Stimulation(10 Hz) + mechanical tactile stimulation
Interventions/Control_2
Transcranial Alternating Current Stimulation(20 Hz) + mechanical tactile stimulation
Interventions/Control_3
Transcranial Alternating Current Stimulation(sham) + mechanical tactile stimulation
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years and older
Key exclusion criteria
taking medications, those with metal implants in their bodies, those who are pregnant, those with a history of central nervous system disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kojima |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
TEL
025-257-4312
kojima@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kojima |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198, Japan
TEL
025-257-4312
Homepage URL
kojima@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
the 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
Niigata University of Health and Welfare
Address
Institute for Human Movement and Medical Sciences
Tel
025-257-4312
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
| 2025 | Year | 12 | Month | 22 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068812
