RecruitingNot ApplicableNCT06561919

STIMPulseControl Ancillary Speech Study


Sponsor

Steffen Paschen

Enrollment

60 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is an ancillary (add-on) sub-study attached to the main STIMPulseControl trial (KKS-313), which is investigating a brain stimulation treatment for a neurological or movement-related condition. This sub-study focuses specifically on measuring how the stimulation affects speech production and vocal function over time, using detailed speech recordings and analysis. **You may be eligible if...** - You are already enrolled in, or eligible to enroll in, the main STIMPulseControl study - You meet all inclusion criteria outlined in the main study protocol - You are willing to undergo additional speech assessments as part of this sub-study **You may NOT be eligible if...** - You meet any of the exclusion criteria for the main STIMPulseControl study - You are unwilling or unable to participate in the speech-related assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbilateral 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

DRUGbest 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


Locations(12)

University Hospital Cologne

Cologne, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

University Hospital Duesseldorf

Düsseldorf, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

University Hospital Schleswig-Holstein (UKSH), Campus Kiel

Kiel, Germany

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

Marburg, Germany

Charité Campus Mitte

Mitte, Germany

University Hospital Tuebingen

Tübingen, Germany

University Hospital Wuerzburg

Würzburg, Germany

Amsterdam University Medical Center

Amsterdam, Netherlands

University Hospital of Bern (Inselspital)

Bern, Switzerland

University Hospital Zuerich (USZ)

Zurich, Switzerland

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NCT06561919


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