NCT02498158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 12, 2015

Last Update Submit

July 19, 2015

Conditions

Functional Neural Connectivity

Outcome Measures

Primary Outcomes (1)

  • functional neural connectivity

    MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.

    one day

Study Arms (1)

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

Interventions

MRI scansDEVICE

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.

experimental protocol

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • generally healthy subjects
  • underwent heat injury in the past two months
  • underwent Heat Tolerance Test at the Heller Institute of Medical research

You may not qualify if:

  • drug or alcohol use
  • history of neurological disorders, mental retardation or head injury
  • history or diagnosis of psychiatric disorders
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ofir Frenkel, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofir Frenkel, M.D

CONTACT

+972529243399Ofir.Frenkel@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2015

First Posted

July 15, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

IL(1)