Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat (fMRI)

July 19, 2015 updated by: Sheba Medical Center

Functional Neural Connectivity at Rest, as a Diagnostic Tool for Intolerance to Heat and Return to Duty After Exertional Heat Stroke

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.

Study Overview

Status

Unknown

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ramat- Gan
      • Tel-Hashomer, Ramat- Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

population of soldiers from the israeli defence forces (IDF), healthy in general, who had gone through heat injury (heat fatigue or hyperthermia) in the two month prior to their recruitment.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  1. anatomical scan according to standard protocol
  2. functional scan according to the standard protocol of rest-state fMRI.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 12, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 19, 2015

Last Verified

July 1, 2015

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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