Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498158
Recruitment Status : Unknown
Verified July 2015 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Functional Neural Connectivity Device: MRI scans

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Neural Connectivity at Rest, as a Diagnostic Tool for Intolerance to Heat and Return to Duty After Exertional Heat Stroke
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.
Device: MRI scans

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.





Primary Outcome Measures :
  1. functional neural connectivity [ Time Frame: one day ]
    MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498158


Contacts
Layout table for location contacts
Contact: Ofir Frenkel, M.D +972529243399 Ofir.Frenkel@sheba.health.gov.il

Locations
Layout table for location information
Israel
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Ofir Frenkel, M.D Sheba Medical Center
Layout table for additonal information
Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02498158    
Other Study ID Numbers: 2380-15-SMC
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015