Tokyo, March 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060923) titled 'Investigation of the effects of thermal stimulation on cognitive task load and brain activity' on March 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069722
Disclaimer: Curated by HT Syndication.