- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498158
Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat (fMRI)
Functional Neural Connectivity at Rest, as a Diagnostic Tool for Intolerance to Heat and Return to Duty After Exertional Heat Stroke
Study Overview
Detailed Description
20 healthy subjects that had already underwent Heat Tolerance Test (HTT) at the Heller Institute of Medical Research (Sheba Medical Center) will be recruited and divided into 2 groups: heat tolerant and heat intolerant (according to the HTT results). They will be asked to arrive to one experimental day at the imaging department in Sheba Medical Center and undergo anatomical and functional MRI scans.
Third group will consist of 10 existing brain scans (separated from personal details) of healthy males, at the same age range and who had never gone through heat injury.
Data will be analysed by fMRI expert in order to compare the functional neural connectivity at rest between the three groups.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ramat- Gan
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Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- generally healthy subjects
- underwent heat injury in the past two months
- underwent Heat Tolerance Test at the Heller Institute of Medical research
Exclusion Criteria:
- drug or alcohol use
- history of neurological disorders, mental retardation or head injury
- history or diagnosis of psychiatric disorders
- claustrophobia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
experimental protocol
Functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and healthy subjects) will be assessed using the anatomical and functional MRI scans and compared.
|
20 subject (10 tolerant and 10 intolerant to heat) will undergo MRI scans (GE healthcare manufacturer) as follows:
scans of 10 healthy subjects will be taken from existing scans at the imaging department. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional neural connectivity
Time Frame: one day
|
MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.
|
one day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2380-15-SMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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