Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT01628003
Status:
UNKNOWN
Last Update Posted:
2012-06-26
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Reserves After Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological battery', 'timeFrame': 'neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'long-term outcome', 'Brain Reserves', 'Cognitive Reserves', 'Emotional Reserves', 'Patients 1 year or more after Moderate or Severe Traumatic Brain Injury'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.\n\nThe purpose of this study are:\n\n1. to determine whether such reserves exist.\n2. to study their convergent and discriminant validity.\n3. to study their characteristics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate-Severe Traumatic Brain Injury according to at least 1 the following:\n\n * Duration of loss of consciousness (LOC) - more then 1/2 hour\n * Glasgow Coma Scale (GCS) - less then 13\n * Post Traumatic Amnesia (PTA) - more then 24 hours.\n* At least 1 year after the injury.\n\nExclusion Criteria:\n\n* Mild Traumatic Brain Injury\n* the present state of Post Traumatic Amnesia\n* dementia\n* the age less than 18 years on the moment of injury\n* less than 1 year since the injury\n* incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)\n* premorbid diagnosis of Mental Retardation'}, 'identificationModule': {'nctId': 'NCT01628003', 'briefTitle': 'Study of Reserves After Traumatic Brain Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'SHEBA-09-7297-AS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'healthy persons', 'interventionNames': ['Device: Brain MRI', 'Device: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'patients after moderate-severe TBI', 'interventionNames': ['Device: Brain MRI', 'Device: MRI']}], 'interventions': [{'name': 'Brain MRI', 'type': 'DEVICE', 'description': 'Brain MRI', 'armGroupLabels': ['healthy persons', 'patients after moderate-severe TBI']}, {'name': 'MRI', 'type': 'DEVICE', 'description': 'Physical examination Neuropsychological testing Questionnaires', 'armGroupLabels': ['healthy persons', 'patients after moderate-severe TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Tel Hashomer Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}