UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062649 |
|---|---|
| Receipt number | R000071715 |
| Scientific Title | The Effects of Mechanical Tactile Stimulation Interventions on Somatosensory and Autonomic Nervous System Function |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/21 17:13:05 |
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Basic information
Public title
The Effects of Mechanical Tactile Stimulation Interventions on Somatosensory and Autonomic Nervous System Function
Acronym
The Effects of Mechanical Tactile Stimulation Interventions on Somatosensory and Autonomic Nervous System Function
Scientific Title
The Effects of Mechanical Tactile Stimulation Interventions on Somatosensory and Autonomic Nervous System Function
Scientific Title:Acronym
The Effects of Mechanical Tactile Stimulation Interventions on Somatosensory and Autonomic Nervous System Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate how mechanical tactile stimulation interventions under different conditions affect the excitability of the somatosensory cortex, two-point discrimination (the ability to distinguish between two spatially distinct points) and autonomic nervous system function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram data, electrocardiogram data and two-point discrimination data before and after the intervention
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A condition involving 30 minutes of continuous tactile stimulation using Braille-style plastic pins (24 pins)
Interventions/Control_2
A condition involving 15 minutes of continuous tactile stimulation using Braille-style plastic pins (24 pins)
Interventions/Control_3
A condition involving tactile stimulation using Braille-style plastic pins (24 pins), administered in an intermittent pattern of 15 minutes of stimulation, followed by 15 minutes of rest, and then another 15 minutes of 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
Aged 18 or over
Key exclusion criteria
Individuals with a history of neuropsychiatric disorders, those with severe skin conditions, those taking medication (including central nervous system actives, anxiolytics, antidepressants, hypnotics, antiepileptics and cardiovascular drugs), and any other individuals deemed unsuitable by the investigator
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
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimami, Kita-ku, Niigata-City, 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
Faculty of Rehabilitation
Zip code
950-3198
Address
1398, Shimami, Kita-ku, Niigata-City, 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
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
Niigata University of Health and Welfare
Address
1398, Shimami, Kita-ku, Niigata-City, 950-3198, Japan
Tel
025-257-4312
kojima@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 | 08 | Month | 24 | 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 | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | 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 | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071715
