UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060923 |
|---|---|
| Receipt number | R000069722 |
| Scientific Title | Investigation of the effects of thermal stimulation on cognitive task load and brain activity |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/13 14:25:04 |
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Basic information
Public title
Investigation of the effects of thermal stimulation on cognitive task load and brain activity
Acronym
Investigation of the effects of thermal stimulation on cognitive task load and brain activity
Scientific Title
Investigation of the effects of thermal stimulation on cognitive task load and brain activity
Scientific Title:Acronym
Investigation of the effects of thermal stimulation on brain network mechanisms
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate fatigue-related changes in brain networks and to examine, within the same participants, the extent to which thermal stimulation affects the fatigue-associated decreases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain network connectivity measured using resting-state functional MRI before and after the fatigue task and warm and cold thermal stimulation
Key secondary outcomes
Mean response (answer) time and the number of incorrect responses (errors) for each cognitive task
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Thermal stimulation will be applied during a 60-minute cognitive task session -> 2-week washout -> 60-minute cognitive task session without intervention
Interventions/Control_2
60-minute cognitive task session without intervention -> 2-week washout ->Thermal stimulation will be applied during a 60-minute cognitive task session
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Males aged 20-59 who are right-handed.
2. Full-time (regular) employees working at Kao Corporation's Odawara and Sumida sites.
3. Individuals who can understand and respond to questionnaires written in Japanese.
Key exclusion criteria
1. Individuals who do not meet the requirements for undergoing MRI measurements.
2. Individuals who are sensitive to cold.
3. Individuals who are uncomfortable with cold stimuli.
4. Individuals who find it difficult to use, or are uncomfortable using, medicated
patches (topical compress/patch preparations).
5. Individuals who dislike the scent of bergamot or mint.
6. Individuals who have a strong reaction to alcohol swabs (alcohol-impregnated cotton).
7. Individuals whom the principal investigator deems unsuitable for participation for any other reason, such as noncompliance with study obligations.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Human Healthcare Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131- 8501, JAPAN
TEL
+81-3-5630-7268
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Motohashi |
Organization
Kao Corporation
Division name
Human Healthcare Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131- 8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
motohashi.hiroaki@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131- 8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 03 | 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 | 03 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 24 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069722
