EMO-SPEECH-PD: SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
With 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.
Even in healthy subjects, speech changes in a situational manner, due to which the investigators will also include healthy subjects as a control group.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parkinson's disease patients with DBS All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus |
Other: Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication
Other: DBS OFF state
Turning off the stimulation during experiment
Other: Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication
Other: DBS ON state
Experiment will be performed with stimulation (ON condition)
|
| Experimental: Parkinson's disease patients without DBS All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus |
Other: Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication
Other: Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication
|
| No Intervention: Healthy Controls All healthy volunteers |
Outcome Measures
Primary Outcome Measures
- Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients [Visit 2 (< 3 months)]
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 [Visit 2 (< 3 months)]
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 [Visit 2 (< 3 months)]
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 [Visit 2 (< 3 months)]
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 Outcome Measures
- Dyskinesia severity [At visit 1 (baseline) and visit 2 (< 3 months)]
Score on Marconi dyskinesia rating scale [0-28 pts.]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.
- Momentary mood state [At visit 1 (baseline) and visit 2 (< 3 months)]
Score on Visual Analogue Mood Scale (VAMS) [0-100 pts.]. Higher scores in VAMS means better mood.
- Momentary anxiety state [At visit 1 (baseline) and visit 2 (< 3 months)]
Score on Visual Analogue Anxiety Scale (VAAS) [0-100 pts.]. Higher scores in VAAS means more anxiety.
- Bradyphrenia assessment [At visit 1 (baseline) and visit 2 (< 3 months)]
Score on Bradyphrenia scale [0-72 pts.]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.
Other Outcome Measures
- Severity of non-motor aspects of experiences of Daily Living [< 2 weeks from the baseline visit]
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 [< 2 weeks from the baseline visit]
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 [< 2 weeks from the baseline visit]
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 [< 2 weeks from the baseline visit]
Score on Parkinson's Disease Questionnaire, 8 items (PDQ-8) [0-32 pts.]. Higher scores in PDQ-8 scale means worse quality of life
- Dysarthria severity assessment [< 2 weeks from the baseline visit]
Score on Voice Handicap Index (VHI) [0-120 pts.]. Higher scores in VHI scale means more severe dysarthria (speech impairment)
- Anxiety and depressive symptomatology [< 2 weeks from the baseline visit]
Score on Hospital Anxiety and Depression Scale (HADS) [0-60 pts.]. Higher scores in HADS scale means more severe anxiety and depressive symptoms
- Apathetic symptomatology [< 2 weeks from the baseline visit]
Score on Starkstein Apathy Scale (SAS) [0-42 pts.]. Higher scores in SAS scale means more severe apathetic symptoms
- Impulse-control disorders assessment [< 2 weeks from the baseline visit]
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
Eligibility Criteria
Criteria
Patients with Parkinson's Disease
Inclusion Criteria:
-
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;
-
Fluent in German or French
Exclusion Criteria:
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Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);
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Clinical diagnosis of aphasia;
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Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
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Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
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Depression with acute suicidal ideation
Healthy Controls
Inclusion Criteria:
-
Written informed consent
-
Adults from 50-70 years old;
-
Fluent in German or French
Exclusion Criteria:
-
Diagnosis of Parkinson's disease;
-
Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
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Suffering from brain disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.);
-
Clinical diagnosis of aphasia, dysarthria, and stuttering;
-
Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Czech Technical University Prague | Prague | Czechia | 166 27 | |
| 2 | University Hospital Inselspital, Berne | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- Czech Technical University in Prague
Investigators
- Principal Investigator: Paul Krack, Prof., University Hospital Inselspital, Berne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-01304