STIMPulseControl Ancillary Speech Study

Condition(s) studied

Investigational drug(s) / intervention(s)

bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper: Best 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: Best medical treatment according to widely accepted consensus Paper

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (13)

Other trials for the same condition