Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 6:13 PM
Study NCT ID:
NCT01320306
Status:
TERMINATED
Last Update Posted:
2019-04-26
First Post:
2011-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Aneurysms and Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Could not be implemented', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'Each subject will undergo one assessment of cognitive function. The assessment lasts about 2.5 hours including breaks.', 'description': 'Neuropsychological Assessment'}], 'secondaryOutcomes': [{'measure': 'Neurological status', 'timeFrame': 'Each subject will undergo one clinical assessment of neurological status.', 'description': 'A clinical examination of neurological status'}, {'measure': 'fMRI', 'timeFrame': 'A subgroup of patients will participate in a fMRI study once', 'description': 'A subgroup of patients will participate in a fMRI study once'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intracranial Aneurysms']}, 'referencesModule': {'references': [{'pmid': '18818402', 'type': 'BACKGROUND', 'citation': 'Isaksen JG, Bazilevs Y, Kvamsdal T, Zhang Y, Kaspersen JH, Waterloo K, Romner B, Ingebrigtsen T. Determination of wall tension in cerebral artery aneurysms by numerical simulation. Stroke. 2008 Dec;39(12):3172-8. doi: 10.1161/STROKEAHA.107.503698. Epub 2008 Sep 25.'}, {'pmid': '16138132', 'type': 'BACKGROUND', 'citation': 'Sandell T, Isaksen J, Bajic R, Ingebrigtsen T. [Treatment of intracranial aneurysms]. Tidsskr Nor Laegeforen. 2005 Aug 25;125(16):2188-91. Norwegian.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence rate of intracranial aneurysms in the adult population is close to 5%. Rupture risk of such aneurysms causing subarachnoid hemorrhage (SAH) can be substantial.Most patients suffering from an aneurysmal SAH are in their mid life, i.e., 30 to 60 years old. Aneurysmal SAH may cause disability and mortality. The present study includes a follow-up study and a cross-sectional fMRI study. The purpose of the follow-up study is to monitor patients receiving prophylactic surgical treatment of their un-ruptured aneurysms to examine whether such treatment is associated with cognitive, psychosocial and/or neurologic sequela. The purpose of the cross-sectional fMRI study is to examine the relationship between memory function and brain activity among SAH patients. Memory impairment is often found among aneurysmal SAH patients. Using fMRI can possibly shed some light on whether such memory impairment may be caused by diffuse cerebral damage or a focal damage at the aneurysm site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.A subgroup of patients suffering aneurismal subarachnoid hemorrhage.\n\nUniversity Hospital of North Norway', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with un-ruptured aneurysms in the anterior communicating artery and the middle cerebral artery.\n* A subgroup of patients suffering aneurismal subarachnoid hemorrhage.\n\nExclusion Criteria:\n\n* History of earlier cerebrovascular, psychiatric or neurological disease.\n* Age older than 75 years\n* Lack of fluency in Norwegian\n* Alcohol or Substance abuse\n* Aphasia\n* Substantial vision or hearing deficits'}, 'identificationModule': {'nctId': 'NCT01320306', 'briefTitle': 'Intracranial Aneurysms and Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Intracranial Aneurysms and Cognitive Function', 'orgStudyIdInfo': {'id': '2010/2292-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subarachnoid hemorrhage', 'description': 'A group of patients suffering aneurismal subarachnoid hemorrhage will participate in a fMRI study.'}, {'label': 'Prophylactic surgical treatment of un-ruptured aneurysms', 'description': 'A retrospective follow-up study of patients who have received prophylactic surgical treatment of un-ruptured aneurysms'}, {'label': 'Conservative treatment', 'description': 'A retrospective follow-up of patients receiving conservative (life stile etc.) treatment of un-ruptured aneurysms.'}, {'label': 'Control group of healthy subjects', 'description': 'Control group of healthy subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Tor Ingebrigtsen, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of North Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}