UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061399 |
|---|---|
| Receipt number | R000070250 |
| Scientific Title | Impact of Heat Stress on Neurovascular Coupling and Cognitive Function |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/28 12:06:32 |
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Basic information
Public title
A Study on the Effects of Heat Stress on Brain and Cognitive Function
Acronym
HEAT-Brain Study
Scientific Title
Impact of Heat Stress on Neurovascular Coupling and Cognitive Function
Scientific Title:Acronym
HEAT-NVCC
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
This study is a basic study designed to elucidate the mechanisms of neurovascular coupling disruption and cognitive decline induced by heat stress through the assessment of physiological responses.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the effect of heat stress on brain activity, which will be primarily assessed using BOLD signals measured by fMRI.
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
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Seated resting condition
Interventions/Control_2
Passive heating resting condition
Interventions/Control_3
Exercise condition
Interventions/Control_4
Heat stress exercise condition
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
| 40 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tarumi |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Research Strategy Headquarters, Self-Care Technology Research Center
Zip code
3058566
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, Japan
TEL
08022167322
takashi.tarumi@aist.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tarumi |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Research Strategy Headquarters, Self-Care Technology Research Center
Zip code
3058566
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, Japan
TEL
08022167322
Homepage URL
takashi.tarumi@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology in Japan
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
National Institute of Advanced Industrial Science and Technology, AIST bioethics committee
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, Japan
Tel
0298612120
safe-life-ml@aist.go.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 | 06 | Month | 01 | 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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070250
