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| Name | Class |
|---|---|
| Czech Technical University in Prague | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Philipps University Marburg | OTHER |
| University Hospital Schleswig-Holstein |
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Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.
Speech of all study patients enrolled in the STIMPulseControl main study will be recorded at three points of time in a standardized way. Following this ancillary protocol, patients speech will be recorded at the baseline visit (preoperatively), at the 6-months visit and at the 12-months visit postoperatively.
For the baseline speech assessment the same protocol will be performed in chronic medication conditions. At 12-month follow up, we will repeat the speech protocol in chronic medication and stimulation condition. The recordings will be done in each centre in a decentralized way and the audio files will be produced according to a standardized protocol, and assisted by a step-by-step guided speech recording software.
Main aims and hypothesis for automated speech analysis study are safety measures for surgical interventions in PD assessment of parkinsonian (hypokinetic) motor speech features outcome after STN-DBS, assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS, assessment of capsular speech features outcome after STN-DBS in PD emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD assessment of acoustic and linguistic speech features as proxy for behaviour and cognitive changes in PD, comparison of emotional and cognitive speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS-group | Other | Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic necleus combined with best medical treatment |
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| BMT-group | Other | Within indication and clinical routine: best medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper | Procedure | Best medical treatment according to widely accepted expert consensus Paper |
| Measure | Description | Time Frame |
|---|---|---|
| Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS | primary aim: To globally assess motor speech features of PD change after STN-DBS intervention. Outcome: A compound score resulting from the normalized average of the main speech domains of hypokinetic dysarthria (i.e.phonation, articulation, prosody and timing) will be analyzed. For example, as proxy of phonation/voice quality, harmonics-to-noise ratio will be used. For the assessment of articulation changes, voice to onset (VOT) and Resonant frequency attenuation (RFA) will be assessed. Monopitch, will be assessed using the standard deviation of fundamental frequency (sdF0), while reduced intensity of speech variability or monoloudness will be assessed using the standard deviation of speech intensity (sdInt). To assess timing abnormalities seen in PD, prolonged pauses (PrLP), disrupting natural rhythm of speech, will be used. | 12 months |
| Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD | primary aim: To assess how paralinguistic speech content changes after STN-DBS intervention. Outcome: A compound score resulting from the normalized average of the main emotional paralinguistic features (such as pitch variability; duration of voiced segments, pause durations and intensity variability). | 12 months |
| Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD | primary aim: To assess how semantic speech content changes after STN-DBS intervention. Outcome: A compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PART I/B: Safety measures for surgical interventions in PD | secondary aim B: Comparison of paralinguistic speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone. Outcome: Comparison of the rate of change of the compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio). | 12 months |
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Inclusion Criteria:
Please refer to main study (STIMPulseControl KKS-313)
Exclusion Criteria:
Please refer to main study (STIMPulseControl KKS-313)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steffen Paschen, MD | Contact | 0049 431 500 23819 | steffen.paschen@uksh.de | |
| Günter Deuschl, Prof. Dr. | Contact | 0049 431 500 238956 | g.deuschl@neurologie.uni-kiel.de |
| Name | Affiliation | Role |
|---|---|---|
| Jan Rusz, Prof. | Czech Technical Iniversity in Prague, Faculty of Electrical Engineering | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Cologne | Recruiting | Cologne | Germany |
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| OTHER |
| Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) | OTHER |
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|
| best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper | Drug | Best medical treatment according to widely accepted consensus Paper |
|
| PART I/B: Safety measures for surgical interventions in PD | secondary aim B: Comparison of semantic speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone. Outcome: Comparison of the rate of change of the compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio). | 12 months |
| PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD | secondary aim C: Assessment of capsular speech features outcome after STN-DBS in PD. Outcome: A compound score resulting from the normalized average of the main speech features affected by capsular stimulation induced side-effects (such as net speech rate and pitch breaks during sustained phonation). | 12 months |
| PART I/A: Safety measures for surgical interventions in PD | secondary aim A: Assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS. Outcome: A compound score resulting from the normalized average of the main speech features affected by dyskinesia (such as intensity variability, breading capacity and spectral features variability). | 12 months |
| University Hospital Carl Gustav Carus | Recruiting | Dresden | Germany |
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| University Hospital Duesseldorf | Recruiting | Düsseldorf | Germany |
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| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
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| University Hospital Schleswig-Holstein (UKSH), Campus Kiel | Recruiting | Kiel | Germany |
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| University Hospital of Giessen and Marburg (UKGM), Campus Marburg | Recruiting | Marburg | Germany |
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| Charité Campus Mitte | Recruiting | Mitte | Germany |
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| University Hospital Tuebingen | Recruiting | Tübingen | Germany |
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| University Hospital Wuerzburg | Recruiting | Würzburg | Germany |
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| Amsterdam University Medical Center | Recruiting | Amsterdam | Netherlands |
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| University Hospital of Bern (Inselspital) | Recruiting | Bern | Switzerland |
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| University Hospital Zuerich (USZ) | Recruiting | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D013060 | Speech |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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