About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper
Procedure/SurgeryBest medical treatment according to widely accepted expert consensus Paper
best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper
DrugBest medical treatment according to widely accepted consensus Paper
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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).
Secondary outcomes
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).
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).
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).
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).
Sponsors and contacts
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Steffen Paschen
Lead sponsor
University of Kiel
Sponsor institution
Czech Technical University in Prague
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Philipps University Marburg
Collaborator
University Hospital Schleswig-Holstein
Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborator