STIMPulseControl Ancillary Speech Study

NCT06561919 | Recruiting

• 1 other identifier: KKS-313-A
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 12

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

Keywords

Speech

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• PART I/B: Safety measures for surgical interventions in PD

  12 months

• PART I/B: Safety measures for surgical interventions in PD

  12 months

• PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD

  12 months

• PART I/A: Safety measures for surgical interventions in PD

  12 months

Study Arms (2)

DBS-group

OTHER

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

BMT-group

OTHER

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

Interventions

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

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

DBS-group

best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper DRUG

Best medical treatment according to widely accepted consensus Paper

BMT-group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Please refer to main study (STIMPulseControl KKS-313)

You may not qualify if:

• Please refer to main study (STIMPulseControl KKS-313)

Sponsors & Collaborators

• Steffen Paschen: lead
• Czech Technical University in Prague: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Philipps University Marburg: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator

Study Sites (12)

University Hospital Cologne

Cologne, Germany

RECRUITING

University Hospital Carl Gustav Carus

Dresden, Germany

RECRUITING

University Hospital Duesseldorf

Düsseldorf, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

University Hospital Schleswig-Holstein (UKSH), Campus Kiel

Kiel, Germany

RECRUITING

University Hospital of Giessen and Marburg (UKGM), Campus Marburg

Marburg, Germany

RECRUITING

Charité Campus Mitte

Mitte, Germany

RECRUITING

University Hospital Tuebingen

Tübingen, Germany

RECRUITING

University Hospital Wuerzburg

Würzburg, Germany

RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

University Hospital of Bern (Inselspital)

Bern, Switzerland

RECRUITING

University Hospital Zuerich (USZ)

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders; Verbal Behavior; Communication; Behavior

Study Officials

• Jan Rusz, Prof.

  Czech Technical Iniversity in Prague, Faculty of Electrical Engineering

  STUDY CHAIR

Central Study Contacts

Steffen Paschen, MD

CONTACT

0049 431 500 23819; steffen.paschen@uksh.de

Günter Deuschl, Prof. Dr.

CONTACT

0049 431 500 238956; g.deuschl@neurologie.uni-kiel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 20, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); DE (9); NL (1)