Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-01 @ 5:40 PM
Study NCT ID:
NCT05954468
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psycho-social Impact of Anti-NMDAR Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive and psycho-social analyses of patients with NMDAR encephalitis.', 'timeFrame': 'At study completion in an average of 12 months', 'description': 'The analyze will focus on the post-acute phase of the disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['auto-immune encephalitis', 'NMDA receptor encephalitis', 'Health-related quality of life', 'psyco-social impact', 'cognitive consequence'], 'conditions': ['NMDAR Antibody-associated Auto-immune Encephalitis']}, 'descriptionModule': {'briefSummary': "NMDA receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. The majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. However, as the disease was only recently discovered (Dalmau and al. Annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated.\n\nThe proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. Our main hypothesis is that NMDAR encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. Furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study involves patients with autoimmune encephalitis with anti-NMDAR antibodies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with anti-NMDAR encephalitis\n* Year ≥ 18 ans\n* Patients affiliated to the social security scheme\n\nExclusion Criteria:\n\n* Patients with no anti-NMDAR encephalitis\n* Minor patient\n* Patient under guardianship or curatorship\n* Patient with preexisting neurological symptoms'}, 'identificationModule': {'nctId': 'NCT05954468', 'acronym': 'SAPIENCE', 'briefTitle': 'Psycho-social Impact of Anti-NMDAR Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Psycho-social Impact of Anti-NMDAR Encephalitis', 'orgStudyIdInfo': {'id': '69HCL21_0628'}}, 'armsInterventionsModule': {'interventions': [{'name': 'standardized and validated surveys', 'type': 'OTHER', 'description': 'To evaluate the cognitive and psycho-social long term impact of a NMDAR encephalitis, we will collect the data using specific interview assessments such as the PROMS (Patient-reported Outcome Measures Information System) and PREMS (Patient-reported experiences measures) as well as we will check the cognitive performance in order to combine the expertise from clinical neurology, social \\& health psychology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'state': 'Bron', 'country': 'France', 'facility': 'Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}