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

Functional Neural Connectivity Clinical Trial

— fMRI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02498158
• Other study ID #: 2380-15-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 19, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Functional Neural Connectivity

Intervention

Device:
• MRI scans
20 subject (10 tolerant and 10 intolerant to heat) will undergo MRI scans (GE healthcare manufacturer) as follows: anatomical scan according to standard protocol 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.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional neural connectivity	MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.	one day	No