Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-22 @ 12:10 PM
Study NCT ID:
NCT00664157
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2008-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2008-04-21', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial expression recognition test', 'timeFrame': '% of exact responses'}], 'secondaryOutcomes': [{'measure': 'Lexical decision test', 'timeFrame': 'The time to respond'}]}, 'conditionsModule': {'keywords': ["Idiopathic Parkinson's disease", 'L-Dopa', 'Deep Brain stimulation', 'Facial expression recognition of emotion', 'Frequency levels', 'Automatic and voluntary information treatment', "Patient with an Idiopathic Parkinson's disease"], 'conditions': ["Idiopathic Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is now considered the gold standard surgical treatment.\n\nParkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the limbic system and could be responsible of a specific trouble in the recognition in some facial expression.\n\nWe hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and automatic treatment of emotional information.\n\nThe main purpose of this study is to show if patients with Parkinson'disease present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).\n\nWe also examine the role of L-Dopa and the deep brain stimulation on emotion perception", 'detailedDescription': "40 patients with an Idiopathic Parkinson's disease divided in two groups :\n\n* 20 patients evaluated before surgery and 6 month after surgery\n* 20 patients only evaluated after surgery.\n\n 40 paired healthy volunteers\n\n 1\\) Study progress (patients):\n\nInclusion visit :\n\nNeurological evaluations .\n\nNeuropsychological evaluations : MMS, MADRS, MATTIS, BREF, Wisconsin test, Apathy test, Benton….\n\nOphthalmic visit : VISTECH\n\nProtocol :\n\n1. for patients evaluated before surgery Facial expression recognition test Lexical decision test Made in two conditions : without the treatment (Med OFF) and one hour after the L-Dopa administration (MED ON)\n2. for patients evaluated after surgery Facial expression recognition test Lexical decision test Made in four conditions\n\n * Without stimulation (STIM OFF) and medication (MED OFF)\n * MED OFF and STIM ON\n * MED ON and STIM OFF\n * MED ON and STIM ON\n\n 2\\) Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 30-75 years\n* Patient with an idiopathic Parkinson\'s disease according to the criteria of the "Parkinson\'s Disease Society Brain Bank" (Hughes et al., 1992)\n* Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson\'s disease (Consensus Conference Proceeding, 2000)\n* Effect of the stimulation 50%\n* Affiliation to social security\n* Agreement of patients\n\nExclusion Criteria:\n\n* Patients suffering of an atypical Parkinson syndrome\n* Patients with severe tremor before surgery\n* Patients with a vision contrast altered.\n* Patients who do not understand the words associated with an emotion\n* Pregnant women\n* Person who participate to an other study'}, 'identificationModule': {'nctId': 'NCT00664157', 'briefTitle': "Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus .", 'orgStudyIdInfo': {'id': 'CHU-0033'}, 'secondaryIdInfos': [{'id': 'RBHP 2007 Durif'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '2', 'description': "40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)", 'interventionNames': ['Behavioral: Facial expression recognition of emotion']}], 'interventions': [{'name': 'Facial expression recognition of emotion', 'type': 'BEHAVIORAL', 'description': 'Facial expression recognition test Lexical decisiontest', 'armGroupLabels': ['2']}, {'name': 'Facial expression recognition of emotion', 'type': 'BEHAVIORAL', 'description': 'Facial expression recognition test Lexical decision test', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Franck Durif, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Durif', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}