Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT05878002
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2034-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-stroke cognitive dysfunction', 'timeFrame': 'Within 72 hours', 'description': 'Assessment through the MoCA (Montreal Cognitive Assessment) score of cognitive dysfunction in patients with acute ischemic stroke treated with mechanical thrombectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-stroke Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to learn about the clinical outcomes of acute ischemic stroke treated with mechanical thrombectomy resulting in a selective ischemia of the basal ganglia. The main question it aims to answer is:\n\n• defining the prevalence and clinical features of possible cognitive, motor and sleep disfuncions occuring after acute ischemic stroke treated with thrombectomy\n\nParticipants will be tested for cognitive, movement and sleep disorders in the acute phase and successively in the long term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* participant's age ≥ 18 years\n* acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B)\n* signature of specific written informed consent\n\nExclusion Criteria:\n\n* unstable clinical conditions\n* personal history of cognitive decline before the acute ischemic stroke"}, 'identificationModule': {'nctId': 'NCT05878002', 'acronym': 'CMS - SBGT', 'briefTitle': '"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': '"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"', 'orgStudyIdInfo': {'id': '5137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients affected by acute ischemic stroke treated with mechanical thrombectomy', 'interventionNames': ['Device: polysomnography']}], 'interventions': [{'name': 'polysomnography', 'type': 'DEVICE', 'description': 'Sleep study through polysomnographic examination', 'armGroupLabels': ['Patients affected by acute ischemic stroke treated with mechanical thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Torlizzi', 'role': 'CONTACT', 'email': 'flavia.torlizzi@policlinicogemelli.it', 'phone': '+390630156433'}], 'facility': 'Flavia Torlizzi', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Carla Piano', 'role': 'CONTACT', 'email': 'carla.piano@policlinicogemelli.it', 'phone': '0630156433', 'phoneExt': '0039'}, {'name': 'Flavia Torlizzi', 'role': 'CONTACT', 'email': 'flavia.torlizzi@policlinicogemelli.it', 'phone': '0630156433', 'phoneExt': '0039'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}