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

NCT ID: NCT02498158

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Functional Neural Connectivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI scans

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ofir Frenkel, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Site Status

Countries

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Israel

Central Contacts

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Ofir Frenkel, M.D

Role: CONTACT

+972529243399

Other Identifiers

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2380-15-SMC

Identifier Type: -

Identifier Source: org_study_id

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