STIMPulseControl Ancillary Speech Study

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Impulse Control Disorder
• Intervention / Treatment: Drug: best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper; Procedure: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steffen Paschen, MD; Phone Number: 0049 431 500 23819; Email: steffen.paschen@uksh.de
• Study Contact Backup: Name: Günter Deuschl, Prof. Dr.; Phone Number: 0049 431 500 238956; Email: g.deuschl@neurologie.uni-kiel.de

Study Locations

• Germany
  • Cologne, Germany
    • Recruiting
    • University Hospital Cologne
    • Contact: Michael Barbe, MD
  • Dresden, Germany
    • Recruiting
    • University Hospital Carl Gustav Carus
    • Contact: Bjoern Falkenburger, Prof.
  • Düsseldorf, Germany
    • Recruiting
    • University Hospital Duesseldorf
    • Contact: Alfons Schnitzler, Prof.
  • Hamburg, Germany
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Monika Poetter-Nerger, MD
  • Kiel, Germany
    • Recruiting
    • University Hospital Schleswig-Holstein (UKSH), Campus Kiel
    • Contact: Steffen Paschen, MD
  • Marburg, Germany
    • Recruiting
    • University Hospital of Giessen and Marburg (UKGM), Campus Marburg
    • Contact: David Pedrosa, MD
  • Mitte, Germany
    • Recruiting
    • Charite Campus Mitte
    • Contact: Patricia Krause, MD
  • Tübingen, Germany
    • Recruiting
    • University Hospital Tuebingen
    • Contact: Daniel Weiss, Prof.
  • Würzburg, Germany
    • Recruiting
    • University Hospital Wuerzburg
    • Contact: Jens Volkmann, Prof.
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Center
    • Contact: Rob MA De Bie, Prof.
    • Contact: Annabel von der Weide, MD
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • University Hospital of Bern (Inselspital)
    • Contact: Paul Krack, Prof.
    • Contact: Ines Debove, MD
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zuerich (USZ)
    • Contact: Lennart Stieglitz, Prof.
    • Contact: Fabian Buechele, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)

Exclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BMT-group; 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 consensus Paper
Other: DBS-group; 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; Best medical treatment according to widely accepted expert consensus Paper; Other Names: best medical treatment for manangement of impulse control in Parkinson´s disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Steffen Paschen
• Collaborators: University Hospital Schleswig-Holstein; Czech Technical University in Prague; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC); Insel Gruppe AG, University Hospital Bern; Philipps University Marburg
• Investigators: Study Chair: Jan Rusz, Prof., Czech Technical Iniversity in Prague, Faculty of Electrical Engineering

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Speech
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Behavior; Communication; Verbal Behavior; Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders; Speech
• Other Study ID Numbers: KKS-313-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No