Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 6:38 AM
Study NCT ID:
NCT02498158
Status:
UNKNOWN
Last Update Posted:
2015-07-21
First Post:
2015-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-19', 'studyFirstSubmitDate': '2015-07-12', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional neural connectivity', 'timeFrame': 'one day', 'description': 'MRI scans will be interpreted by fMRI expert and then compared between heat tolerant and intolerant subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Functional Neural Connectivity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThird 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.\n\nData will be analysed by fMRI expert in order to compare the functional neural connectivity at rest between the three groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* generally healthy subjects\n* underwent heat injury in the past two months\n* underwent Heat Tolerance Test at the Heller Institute of Medical research\n\nExclusion Criteria:\n\n* drug or alcohol use\n* history of neurological disorders, mental retardation or head injury\n* history or diagnosis of psychiatric disorders\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT02498158', 'acronym': 'fMRI', 'briefTitle': 'Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Functional Neural Connectivity at Rest, as a Diagnostic Tool for Intolerance to Heat and Return to Duty After Exertional Heat Stroke', 'orgStudyIdInfo': {'id': '2380-15-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'experimental protocol', 'description': '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.', 'interventionNames': ['Device: MRI scans']}], 'interventions': [{'name': 'MRI scans', 'type': 'DEVICE', 'description': '20 subject (10 tolerant and 10 intolerant to heat) will undergo MRI scans (GE healthcare manufacturer) as follows:\n\n1. anatomical scan according to standard protocol\n2. functional scan according to the standard protocol of rest-state fMRI.\n\nscans of 10 healthy subjects will be taken from existing scans at the imaging department.', 'armGroupLabels': ['experimental protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'state': 'Ramat- Gan', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Ofir Frenkel, M.D', 'role': 'CONTACT', 'email': 'Ofir.Frenkel@sheba.health.gov.il', 'phone': '+972529243399'}], 'overallOfficials': [{'name': 'Ofir Frenkel, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}