Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-26 @ 5:46 AM
Study NCT ID:
NCT05230095
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Cognition Dysfunctions in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional resonance task score', 'timeFrame': '12 months following the inclusion', 'description': 'In the emotional resonance task, patients are asked to rate the emotional valence of fifteen 3-second silent videos. These movies show emotionally connoted motor interactions between two persons, each of them being depicted by 20 white dots moving on a black background (Point Light Displays (PLD) technique). Among these 15 videos, 5 has a negative valence (making someone cry, sadness, argument, hitting someone and anger), 5 has a positive valence (joy, dancing, giving a flower, laughing and cuddling) and 5 neutral valences (sit, stand, say hello, raise your arms and saw).\n\nThe Emotional resonance score in parkinsonian patients undergoing treatment (dopaminergic or deep brain stimulation) will be compared to their score without treatment (OFF Dopa or OFF stimulation).'}], 'secondaryOutcomes': [{'measure': "Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)", 'timeFrame': '12 months following the inclusion', 'description': "PDQ39 (Parkinson's Disease Questionnaire) is a 39-item self-report questionnaire assessing Parkinsons' disease-specific health and well-being over the last month. PDQ39 provide a summary score of the impact of the illness on functioning and well-being."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'emotional recognition', 'Deep Brain Stimulation'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients likely to participate in the study and verifying the eligibility criteria will be identified within the Neurology C department as part of their neurological follow-up before and after deep brain stimulation.\n\nHealthy volunteers will be recruited among the spouses of the patients or via association like France Parkinson.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor all participants:\n\n* Man or woman\n* Participant not objecting to participation in the study\n* Age ≥ 30 and ≤ 70 years old\n\nSpecific inclusion criteria for patients:\n\n* Patients with Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation\n* Patients able to understand the issues of the study\n\nExclusion Criteria:\n\nFor all participants:\n\n* Person deprived of liberty by judicial or administrative decision\n* Person subject to a legal protection measure (tutorship, curatorship)\n* Person concurrently participating in another research project who may interfere with the results or conclusions of this study\n\nSpecific exclusion criteria for healthy volunteers\n\n* Person presenting or having presented a neurological or psychiatric pathology\n* Person with a serious medical condition\n* Person who has exceeded the annual amount of compensation authorized for participation in research protocols"}, 'identificationModule': {'nctId': 'NCT05230095', 'acronym': 'cognition 2', 'briefTitle': "Social Cognition Dysfunctions in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Social Cognition Dysfunctions in Parkinson's Disease", 'orgStudyIdInfo': {'id': '69HCL21_1154'}, 'secondaryIdInfos': [{'id': '2022-A00216-37', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease patients", 'description': '30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited', 'interventionNames': ['Behavioral: social cognition tests', 'Behavioral: Quality of life self-questionnaire']}, {'label': 'Controls', 'description': '15 healthy volunteers matched in age and sex will be recruited', 'interventionNames': ['Behavioral: social cognition tests']}], 'interventions': [{'name': 'social cognition tests', 'type': 'BEHAVIORAL', 'description': 'The evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene.\n\nPatients will be evaluated twice: one time before the surgery and a second time 1 year after surgery.\n\nHealthy volunteers will be evaluated only one time.', 'armGroupLabels': ['Controls', "Parkinson's disease patients"]}, {'name': 'Quality of life self-questionnaire', 'type': 'BEHAVIORAL', 'description': 'Quality of life will be assessed using a self-administered questionnaire in the patients group only.', 'armGroupLabels': ["Parkinson's disease patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Neurology C department, P. Wertheimer Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}