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STIMPulseControl Ancillary Speech Study

NCT06561919 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-02

No results posted yet for this 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.

Conditions

  • Parkinson Disease
  • Impulse Control Disorder

Interventions

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

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

Sponsors & Collaborators

  • Czech Technical University in Prague

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Philipps University Marburg

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

    collaborator OTHER

  • Steffen Paschen

    lead OTHER

Principal Investigators

  • Jan Rusz, Prof. · Czech Technical Iniversity in Prague, Faculty of Electrical Engineering

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2027-07-15
Completion
2028-07-15

Countries

  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561919 on ClinicalTrials.gov