Functional Neural ConnectivityfMRINCT02498158
Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat
An observational study of Functional Neural Connectivity, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Neural Connectivity
- What is being tested?
- MRI scans
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- generally healthy subjects
- underwent heat injury in the past two months
- underwent Heat Tolerance Test at the Heller Institute of Medical research
Who cannot join
- drug or alcohol use
- history of neurological disorders, mental retardation or head injury
- history or diagnosis of psychiatric disorders
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Neural Connectivity
- Being tested
- MRI scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scansDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional neural connectivity
MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neural ConnectivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofir Frenkel, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498158
- Sponsor's protocol ID
- 2380-15-SMC
- Acronym
- fMRI
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neural Connectivity at Rest, as a Diagnostic Tool for Intolerance to Heat and Return to Duty After Exertional Heat Stroke
- ClinicalTrials.gov ID
- NCT02498158
- Acronym / sponsor ID
- fMRI / 2380-15-SMC
- Conditions
- Functional Neural Connectivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental protocol | – | Device: MRI scansFunctional 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- generally healthy subjects
- underwent heat injury in the past two months
- underwent Heat Tolerance Test at the Heller Institute of Medical research
Key exclusion criteria (4 listed)
- drug or alcohol use
- history of neurological disorders, mental retardation or head injury
- history or diagnosis of psychiatric disorders
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scans20 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. | Device | experimental protocol |
Primary outcome
functional neural connectivity
Time frame: one day
MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofir Frenkel, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neural Connectivity, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofir Frenkel, M.D (+972529243399, Ofir.Frenkel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional neural connectivity (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.