[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498042":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":64,"armGroups":68,"interventions":86,"overallOfficials":103,"centralContacts":107,"locations":117,"responsibleParty":145,"collaborators":147,"id":150,"slug":64,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":64,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":132,"whyStopped":64,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":35},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients","A speech analyser software will allow extraction of basic motor acoustic speech features. The extracted variables that better index the dopaminergic medication or stimulation motor effect assessed with Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - motor score \\[0-132 pts.\\] will be used as primary outcomes in this part. Higher scores in MDS-UPDRS part III means more severe motor symptoms.","Visit 2 (\u003C 3 months)",{"measure":14,"description":15,"timeFrame":12},"Part II: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation neuropsychological effect in Parkinson's disease patients","A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation emotional effect assessed with Neuropsychiatric fluctuations scale (NFS) \\[0-60 pts.\\] will be used as primary outcomes in this part. Higher scores in NFS means more severe neuropsychiatric fluctuations.",{"measure":17,"description":18,"timeFrame":12},"Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients","A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with verbal fluency task will be used as primary outcomes in this part. Higher scores in Fluency task means better outcome.",{"measure":17,"description":20,"timeFrame":12},"A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with Stroop test will be used as primary outcomes in this part. Higher scores in Stroop test means worse outcome.",[22,26,29,32],{"measure":23,"description":24,"timeFrame":25},"Dyskinesia severity","Score on Marconi dyskinesia rating scale \\[0-28 pts.\\]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.","At visit 1 (baseline) and visit 2 (\u003C 3 months)",{"measure":27,"description":28,"timeFrame":25},"Momentary mood state","Score on Visual Analogue Mood Scale (VAMS) \\[0-100 pts.\\]. Higher scores in VAMS means better mood.",{"measure":30,"description":31,"timeFrame":25},"Momentary anxiety state","Score on Visual Analogue Anxiety Scale (VAAS) \\[0-100 pts.\\]. Higher scores in VAAS means more anxiety.",{"measure":33,"description":34,"timeFrame":25},"Bradyphrenia assessment","Score on Bradyphrenia scale \\[0-72 pts.\\]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.",[36,40,43,46,49,52,55,58],{"measure":37,"description":38,"timeFrame":39},"Severity of non-motor aspects of experiences of Daily Living","Score on MDS-UPDRS parts I \\[0-52 pts.\\]. Higher scores in MDS-UPDRS-part I scale means more severe non-motor symptoms on experiences of Daily Living","\u003C 2 weeks from the baseline visit",{"measure":41,"description":42,"timeFrame":39},"Severity of motor aspects of experiences of Daily Living","Score on MDS-UPDRS parts II \\[0-52 pts.\\].Higher scores in MDS-UPDRS-part II scale means more severe motor symptoms on experiences of Daily Living",{"measure":44,"description":45,"timeFrame":39},"Severity of motor fluctuations","Score on MDS-UPDRS parts IV \\[0-24 pts.\\]. Higher scores in MDS-UPDRS-part IV scale means more severe motor fluctuations",{"measure":47,"description":48,"timeFrame":39},"Quality of life assessment","Score on Parkinson's Disease Questionnaire, 8 items (PDQ-8) \\[0-32 pts.\\]. Higher scores in PDQ-8 scale means worse quality of life",{"measure":50,"description":51,"timeFrame":39},"Dysarthria severity assessment","Score on Voice Handicap Index (VHI) \\[0-120 pts.\\]. Higher scores in VHI scale means more severe dysarthria (speech impairment)",{"measure":53,"description":54,"timeFrame":39},"Anxiety and depressive symptomatology","Score on Hospital Anxiety and Depression Scale (HADS) \\[0-60 pts.\\]. Higher scores in HADS scale means more severe anxiety and depressive symptoms",{"measure":56,"description":57,"timeFrame":39},"Apathetic symptomatology","Score on Starkstein Apathy Scale (SAS) \\[0-42 pts.\\]. Higher scores in SAS scale means more severe apathetic symptoms",{"measure":59,"description":60,"timeFrame":39},"Impulse-control disorders assessment","Score on Questionnaire for impulsive-compulsive disorders in Parkinson's Disease-Rating Scale (QUIP-RS) \\[0-112 pts.\\]. Higher scores in QUIP-RS scale means more severe impulsive-compulsive disorders",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":6,"observationalModel":64,"timePerspective":64,"maskingInfo":65},"NON_RANDOMIZED","PARALLEL",null,{"masking":66,"maskingDescription":64,"whoMasked":64},"NONE","Parkinson's disease (PD) affects mobility (motor function), thought processes (cognition) and mood (emotion). The language is one of the most complex programs in humans. It contains information about mobility, thinking and mood at the same time. These three levels of agility, thinking and mood are subject to spontaneous fluctuations and can be influenced by external stimuli such as pictures that induce emotions. In addition, these three levels are influenced on the one hand by Parkinson's disease itself, and on the other hand by its treatment with medication or with deep brain stimulation (DBS). For this reason, the investigators would like to investigate language in Parkinson's disease patients in a very detailed computerized way for motor, cognitive and emotional elements for better management of therapies.\n\nWith this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect fluctuations in motor, mood, and thinking in Parkinson's disease patients.\n\nEven in healthy subjects, speech changes in a situational manner, due to which the investigators will also include healthy subjects as a control group.",[69,78,82],{"label":70,"type":71,"description":72,"interventionNames":73},"Parkinson's disease patients with DBS","EXPERIMENTAL","All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus",[74,75,76,77],"Other: Dopaminergic OFF drug state","Other: DBS OFF state","Other: Dopaminergic ON drug state","Other: DBS ON state",{"label":79,"type":71,"description":80,"interventionNames":81},"Parkinson's disease patients without DBS","All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus",[74,76],{"label":83,"type":84,"description":85,"interventionNames":64},"Healthy Controls","NO_INTERVENTION","All healthy volunteers",[87,91,95,99],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":64},"Dopaminergic OFF drug state","Experiment will be performed without dopaminergic medication",[70,79],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":64},"DBS OFF state","Turning off the stimulation during experiment",[70],{"type":6,"name":96,"description":97,"armGroupLabels":98,"otherNames":64},"Dopaminergic ON drug state","Experiment will be performed with dopaminergic medication",[70,79],{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":64},"DBS ON state","Experiment will be performed with stimulation (ON condition)",[70],[104],{"name":105,"affiliation":5,"role":106},"Paul Krack, Prof.","PRINCIPAL_INVESTIGATOR",[108,113],{"name":105,"role":109,"phone":110,"phoneExt":111,"email":112},"CONTACT","31 66 4 03 71","+41","paul.krack@insel.ch",{"name":114,"role":109,"phone":115,"phoneExt":111,"email":116},"Mario Sousa, MD","31 664 23 49","mario.sousa@insel.ch",[118,130],{"facility":119,"status":120,"city":121,"state":64,"zip":122,"country":123,"countryCode":64,"cosmosGeoPoint":124,"geoPoint":129,"contacts":64},"Czech Technical University Prague","ACTIVE_NOT_RECRUITING","Prague","166 27","Czechia",{"type":125,"coordinates":126},"Point",[127,128],14.42076,50.08804,{"lat":128,"lon":127},{"facility":131,"status":132,"city":133,"state":64,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"University Hospital Inselspital, Berne","RECRUITING","Bern","3010","Switzerland","CH",{"type":125,"coordinates":138},[139,140],7.44744,46.94809,{"lat":140,"lon":139},[143,144],{"name":105,"role":109,"phone":110,"phoneExt":111,"email":112},{"name":114,"role":109,"phone":115,"phoneExt":111,"email":116},{"type":146,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR",[148],{"name":149,"class":6},"Czech Technical University in Prague","100498042",false,"NCT05765110","SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease","EMO-SPEECH-PD","Patients with Parkinson's Disease\n\nInclusion Criteria:\n\n* Written informed consent\n* Idiopathic PD according to the Movement Disorders Society Criteria;\n* Age of participants \\> 30 and ≤ 75 years;\n* Treatment with or without bilateral deep brain stimulation in the subthalamic nucleus;\n* Fluent in German or French\n\nExclusion Criteria:\n\n* Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);\n* Clinical diagnosis of aphasia;\n* Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).\n* Cognitive impairment (Montreal Cognitive Assessment (MoCa) \\\u003C 24\u002F30 points);\n* Depression with acute suicidal ideation\n\nHealthy Controls\n\nInclusion Criteria:\n\n* Written informed consent\n* Adults from 50-70 years old;\n* Fluent in German or French\n\nExclusion Criteria:\n\n* Diagnosis of Parkinson's disease;\n* Cognitive impairment (Montreal Cognitive Assessment (MoCa) \\\u003C 24\u002F30 points);\n* Suffering from brain disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.);\n* Clinical diagnosis of aphasia, dysarthria, and stuttering;\n* Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria",true,"ALL","30 Years","75 Years",{"count":161,"type":162},80,"ESTIMATED","INTERVENTIONAL",[165],"NA","With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect motor, emotional, and cognitive fluctuations in Parkinson's disease patients.",[168],"Parkinson Disease",[170,171,172,173,174,175],"Speech","Emotion","Movement","Cognition","Biomarker","Automated speech analysis","2026-05-21",{"date":178,"type":179},"2026-05-22","ACTUAL",{"date":181,"type":179},"2023-01-03",{"date":183,"type":162},"2026-12-31",{"name":5,"class":6},2]