Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT04449666
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changed hippocampal volume in aSAB', 'timeFrame': '2 weeks', 'description': 'Hypothesis: patients have smaller hippocampal volume than healthy control subjects. For the hippocampal volume a structural MRI scan (3D-MPRAGE) is obtained'}], 'secondaryOutcomes': [{'measure': 'Changed memory function in aSAB', 'timeFrame': '2 weeks', 'description': 'Hypothesis: patients have lower scores in the Visual and Verbal memory test (VVM) than healthy control subjects.'}, {'measure': 'Influence of the type of therapy on the hippocampal volume', 'timeFrame': '2 weeks', 'description': 'Hypothesis: hippocampal volumes differ between aSAH patients with surgical or endovascular treatment.'}, {'measure': 'Influence of the lesion site on the hippocampal volume', 'timeFrame': '2 weeks', 'description': 'Hypothesis: there are no differences between ispi- and contralateral hippocampal volumes'}, {'measure': 'Interrater reliability', 'timeFrame': '2 weeks', 'description': 'Hypothesis: It is expected that there will be no difference in the ratings of hippocampal volume between two independent raters.'}, {'measure': 'Changed intracranial volume in aSAB', 'timeFrame': '2 weeks', 'description': 'Hypothesis: patients have smaller intracranial volume than healthy control subjects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurological rehabilitation', 'Hippocampal volume', 'Memory deficits'], 'conditions': ['Neurologic Disorder', 'Subarachnoid Hemorrhage, Aneurysmal']}, 'referencesModule': {'references': [{'pmid': '16924007', 'type': 'BACKGROUND', 'citation': 'Bendel P, Koivisto T, Hanninen T, Kolehmainen A, Kononen M, Hurskainen H, Pennanen C, Vanninen R. Subarachnoid hemorrhage is followed by temporomesial volume loss: MRI volumetric study. Neurology. 2006 Aug 22;67(4):575-82. doi: 10.1212/01.wnl.0000230221.95670.bf.'}]}, 'descriptionModule': {'briefSummary': 'Neuropsychological and functional long-term consequences of subarachnoid hemorrhages (SAH) represent a great challenge, since sometimes considerable cognitive deficits occur without evidence of substantial brain damage. In this study, we want to examine if the frequently observed memory deficits are associated with hippocampal atrophy.', 'detailedDescription': 'Long-term or even permanent neuropsychological impairments are frequently observed after aneurysmal subarachnoid hemorrhages (aSAH). Among the most common impairments after aSAH are memory deficits. Volumetric MRI studies suggest an association of memory dysfunctions with temporal atrophy, especially of the hippocampus. In a previous study, 77 patients with good or moderate clinical outcome after aSAH were examined one year after discharge (Bendel et al., 2006). Temporomesial atrophy was detected without direct brain damage, e.g. by secondary ischemia. Due to the effects of complex cognitive impairments on the quality of life and participation in social and professional life, this relationship will be examined in more detail in the planned study. Specifically, we will investigate to what extent the frequently observed discrepancy between severe memory impairment and normal structural imaging results (no focal lesions in temporomesial areas) is due to hippocampal atrophy. In contrast to Bender and colleagues, this question will be investigated in the acute phase of the disease, immediately after admission to inpatient neurological rehabilitation.\n\nOver a period of 24 months, 29 neurological rehabilitation patients with aSAH (Hunt \\& Hess grade I and II) are going to be included. Within the first week (day 1 to 7) after study enrollment, a native MRI examination (without contrast agent) is performed, in which a high-resolution 3D-MPRAGE sequence (T1 weighting) is measured in the sagittal plane. After checking the data quality of the 3D-MPRAGE sequence, especially with regard to its suitability for hippocampal volume determination, a comprehensive neuropsychological examination is performed, in which specific memory and attentional functions are tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'neurological rehabilitation patients with aneurysmal subarachnoid hemorrhage (Hunt \\& Hess grade I or II)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* neurological rehabilitation patients in phase B - D\n* at minimum eight weeks after disease onset\n* aneurysmal subarachnoid hemorrhage (Hunt \\& Hess grade I or II)\n* written consent from the patient's legal representative\n* exclusion of pregnancy\n\nExclusion Criteria:\n\n* insufficient cardiorespiratory stability\n* previous brain damage\n* mental disorders (dementia, depression)\n* colonization with multi-resistant pathogens\n* MRI contraindications\n* claustrophobia\n* weight \\> 120 kg"}, 'identificationModule': {'nctId': 'NCT04449666', 'briefTitle': 'Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'BDH-Klinik Hessisch Oldendorf'}, 'officialTitle': 'Investigation of the Relationship Between Hippocampal Volume and Memory Functions in in Patients With Aneurysmal Subarachnoid Hemorrhage (aSAH)', 'orgStudyIdInfo': {'id': 'SAB-VOL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Patients undergoing neurological rehabilitation after aneurysmal subarachnoid hemorrhage', 'interventionNames': ['Diagnostic Test: Neuropsychological assessment and structural MRI']}, {'label': 'Control group', 'description': 'Healthy adults controlled for age, gender and educational status', 'interventionNames': ['Diagnostic Test: Neuropsychological assessment and structural MRI']}], 'interventions': [{'name': 'Neuropsychological assessment and structural MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31840', 'city': 'Hessisch Oldendorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Melanie Boltzmann, PhD', 'role': 'CONTACT', 'email': 'm.boltzmann@bdh-klinik-hessisch-oldendorf.de', 'phone': '0049 5152 781 256'}], 'facility': 'BDH-Clinic Hessisch Oldendorf', 'geoPoint': {'lat': 52.17269, 'lon': 9.24913}}], 'centralContacts': [{'name': 'Melanie Boltzmann, PhD', 'role': 'CONTACT', 'email': 'm.boltzmann@bdh-klinik-hessisch.oldendorf', 'phone': '0049 5152 781 256'}, {'name': 'Simone B Schmidt, PhD', 'role': 'CONTACT', 'email': 'si.schmidt@bdh-klinik-hessisch.oldendorf', 'phone': '0049 5152 781 215'}], 'overallOfficials': [{'name': 'Jens D Rollnik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BDH-Clinic Hessisch Oldendorf'}, {'name': 'Melanie Boltzmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BDH-Clinic Hessisch Oldendorf'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Period of availability begins when results are published, at the earliest in Dec 2022', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication.', 'accessCriteria': 'IPD can be obtained from the principal investigator upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BDH-Klinik Hessisch Oldendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}