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| Name | Class |
|---|---|
| Czech Technical University in Prague | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease patients with DBS | Experimental | All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus |
|
| Parkinson's disease patients without DBS | Experimental | All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus |
|
| Healthy Controls | No Intervention | All healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dopaminergic OFF drug state | Other | Experiment will be performed without dopaminergic medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 (< 3 months) |
| 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. | Visit 2 (< 3 months) |
| 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. | Visit 2 (< 3 months) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (< 3 months) |
| Momentary mood state |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | < 2 weeks from the baseline visit |
| Severity of motor aspects of experiences of Daily Living |
Patients with Parkinson's Disease
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Krack, Prof. | Contact | 31 66 4 03 71 | +41 | paul.krack@insel.ch |
| Mario Sousa, MD | Contact | 31 664 23 49 | +41 | mario.sousa@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Paul Krack, Prof. | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Czech Technical University Prague | Active, not recruiting | Prague | 166 27 | Czechia | ||
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D013060 | Speech |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| DBS OFF state | Other | Turning off the stimulation during experiment |
|
| Dopaminergic ON drug state | Other | Experiment will be performed with dopaminergic medication |
|
| DBS ON state | Other | Experiment will be performed with stimulation (ON condition) |
|
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. |
| Visit 2 (< 3 months) |
Score on Visual Analogue Mood Scale (VAMS) [0-100 pts.]. Higher scores in VAMS means better mood.
| At visit 1 (baseline) and visit 2 (< 3 months) |
| Momentary anxiety state | Score on Visual Analogue Anxiety Scale (VAAS) [0-100 pts.]. Higher scores in VAAS means more anxiety. | At visit 1 (baseline) and visit 2 (< 3 months) |
| Bradyphrenia assessment | Score on Bradyphrenia scale [0-72 pts.]. Higher scores in Bradyphrenia scale means more severe bradyphrenia. | At visit 1 (baseline) and visit 2 (< 3 months) |
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 |
| < 2 weeks from the baseline visit |
| 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 | < 2 weeks from the baseline visit |
| 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 | < 2 weeks from the baseline visit |
| Dysarthria severity assessment | Score on Voice Handicap Index (VHI) [0-120 pts.]. Higher scores in VHI scale means more severe dysarthria (speech impairment) | < 2 weeks from the baseline visit |
| 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 | < 2 weeks from the baseline visit |
| Apathetic symptomatology | Score on Starkstein Apathy Scale (SAS) [0-42 pts.]. Higher scores in SAS scale means more severe apathetic symptoms | < 2 weeks from the baseline visit |
| 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 | < 2 weeks from the baseline visit |
| University Hospital Inselspital, Berne |
| Recruiting |
| Bern |
| 3010 |
| Switzerland |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |