Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061399) titled 'A Study on the Effects of Heat Stress on Brain and Cognitive Function' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - National Institute of Advanced Industrial Science and Technology
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the mechanisms of neurovascular coupling disruption and cognitive decline induced by heat stress. Using MRI, physiological responses including cerebral blood flow, brain temperature, and extracellular fluid dynamics will be comprehensively evaluated during resting states before and after increases in core temperature to elucidate their associations with neurovascular coupling and cognitive function.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Seated resting condition
Interventions/Control_2 - Passive heating resting condition
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1 Individuals who are capable of providing written informed consent independently and voluntarily.
2 Individuals aged 18 to 40 years at the time of consent, with no restriction on sex.
3 Individuals who possess adequate physical capacity to engage in continuous exercise for a duration of 30 minutes.
Key exclusion criteria - 1 Individuals with a history of cardiovascular disease, psychiatric or neurological disorders, cerebrovascular disease, renal failure, or respiratory disease.
2 Individuals whose ability to exercise is limited due to underlying medical conditions.
3 Individuals with systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg.
4 Individuals with a history of habitual smoking within the past year.
5 Individuals who are pregnant or who may be pregnant.
MRI-Specific Exclusion Criteria
1 Individuals with an implanted cardiac pacemaker, artificial heart valve, or vascular stent.
2 Individuals with implanted intracranial aneurysm clips.
3 Individuals who are dependent on life-support devices.
4 Individuals using a cochlear implant.
5 Individuals with implanted neurostimulation devices.
6 Individuals with implanted surgical clips or ferromagnetic materials for hemostasis or electrical conduction.
7 Individuals who have undergone orthopedic treatment involving metallic pins, rods, or similar devices.
8 Individuals with severe claustrophobia.
9 Individuals with a history of severe head trauma or neurosurgical procedures.
10 Individuals with permanent tattoos, including cosmetic tattoos such as eyebrow tattoos.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 15 Day
Date of IRB - 2026 Year 04 Month 16 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2031 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070250
Disclaimer: Curated by HT Syndication.
