About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent
Idiopathic PD according to the Movement Disorders Society Criteria;
Age of participants > 30 and ≤ 75 years;
Treatment with or without bilateral deep brain stimulation in the subthalamic nucleus;
Disqualifiers
Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);
Clinical diagnosis of aphasia;
Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
Trial design
Parallel
Treatments tested in this trial
Dopaminergic OFF drug state
Other interventionExperiment will be performed without dopaminergic medication
DBS OFF state
Other interventionTurning off the stimulation during experiment
Dopaminergic ON drug state
Other interventionExperiment will be performed with dopaminergic medication
DBS ON state
Other interventionExperiment will be performed with stimulation (ON condition)
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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 Stroop test will be used as primary outcomes in this part. Higher scores in Stroop test means worse outcome.
Secondary outcomes
Dyskinesia severity
Score on Marconi dyskinesia rating scale \[0-28 pts.\]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.
Momentary mood state
Score on Visual Analogue Mood Scale (VAMS) \[0-100 pts.\]. Higher scores in VAMS means better mood.
Momentary anxiety state
Score on Visual Analogue Anxiety Scale (VAAS) \[0-100 pts.\]. Higher scores in VAAS means more anxiety.
Bradyphrenia assessment
Score on Bradyphrenia scale \[0-72 pts.\]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.
Other outcomes
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
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Czech Technical University in Prague
Collaborator