An interventional study of bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper and best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper in Parkinson Disease and Impulse Control Disorder, sponsored by Steffen Paschen. Recruiting at 13 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Steffen Paschen · Not applicable, Interventional, and Supportive care
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
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Please refer to main study (STIMPulseControl KKS-313)
Exclusion Criteria:
Please refer to main study (STIMPulseControl KKS-313)
Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic necleus combined with best medical treatment
Procedure: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper
Within indication and clinical routine: best medical treatment
Drug: 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 expert consensus Paper
Also known as: best medical treatment for manangement of impulse control in Parkinson´s disease
Best medical treatment according to widely accepted consensus Paper
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Plan to share: No
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