Brief Summary

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.

Conditions

• Parkinson Disease
• Impulse Control Disorder

Intervention / Treatment

• 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

Primary Outcome Measures

• Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS (12 months)
  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 (12 months)
  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 (12 months)
  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).

Countries

Germany, Netherlands, Switzerland

Locations and Investigators

• University Hospital Cologne, Cologne, Germany (Recruiting)
  • Michael Barbe, MD
• University Hospital Carl Gustav Carus, Dresden, Germany (Recruiting)
  • Bjoern Falkenburger, Prof.
• University Hospital Duesseldorf, Düsseldorf, Germany (Recruiting)
  • Alfons Schnitzler, Prof.
• University Medical Center Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
  • Monika Poetter-Nerger, MD
• Paracelsus - Elena- Klinik, Kassel, Germany (Not yet recruiting)
  • Clemens Jaksch, MD
  • Clemens Jaksch, MD (Principal Investigator)
• University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany (Recruiting)
  • Steffen Paschen, MD
• University Hospital of Giessen and Marburg (UKGM), Campus Marburg, Marburg, Germany (Recruiting)
  • David Pedrosa, MD
• Charité Campus Mitte, Mitte, Germany (Recruiting)
  • Patricia Krause, MD
• University Hospital Tuebingen, Tübingen, Germany (Recruiting)
  • Daniel Weiss, Prof.
• University Hospital Wuerzburg, Würzburg, Germany (Recruiting)
  • Jens Volkmann, Prof.
• Amsterdam University Medical Center, Amsterdam, Netherlands (Recruiting)
  • Rob MA De Bie, Prof.
  • Annabel von der Weide, MD
• University Hospital of Bern (Inselspital), Bern, Switzerland (Recruiting)
  • Ines Debove, MD
  • Paul Krack, Prof.
• University Hospital Zuerich (USZ), Zurich, Switzerland (Recruiting)
  • Lennart Stieglitz, Prof.
  • Fabian Buechele, MD

Study Officials

• Jan Rusz, Prof. (Study Chair) — Czech Technical Iniversity in Prague, Faculty of Electrical Engineering