STIMPulseControl Ancillary Speech Study
NCT Number: NCT06561919
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Impulse Control Disorder
Interventions: PROCEDURE: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper|DRUG: best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper
Sponsor: Steffen Paschen
Collaborators: Czech Technical University in Prague|Insel Gruppe AG, University Hospital Bern|Philipps University Marburg Medical Center|University Hospital Schleswig-Holstein, Campus Kiel|Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-05
Completion Date: 2028-07-15
Locations: Charité Campus Mitte, Berlin-Mitte, Germany|University Hospital Carl Gustav Carus, Dresden, Germany|University Hospital Duesseldorf, Düsseldorf, Germany|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany|University Hospital Cologne, Köln, Germany|University Hospital of Giessen and Marburg (UKGM), Campus Marburg, Marburg, Germany|University Hospital Tuebingen, Tübingen, Germany|University Hospital Wuerzburg, Würzburg, Germany|Amsterdam University Medical Center, Amsterdam, Netherlands|University Hospital of Bern (Inselspital), Bern, Switzerland|University Hospital Zuerich (USZ), Zürich, Switzerland

Summary:
Speech assessment is a substudy to STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voice, which will be recorded as part of a speech analysis in the main study, for this optional ancillary study.

Primary Outcome Measures: Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS, Primary aim: To globally assess how 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 theassessment of articulation changes, voice to onset (VOT) and Resonant frequency attenuation (RFA) willbe 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 standarddeviation 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 semantic speech content change 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|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 change 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
Secondary Outcome Measures: 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|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|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