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Recruiting NCT06561919

STIMPulseControl Ancillary Speech Study

No phase Interventional Parkinson Disease Impulse Control Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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 for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper.
Who it may be relevant to
Registry conditions: Parkinson Disease, Impulse Control Disorder. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Netherlands, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

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

Primary outcome measures

  • Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS [Time frame: 12 months]
  • Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD [Time frame: 12 months]
  • Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD [Time frame: 12 months]
Secondary outcome measures (4)
  • PART I/B: Safety measures for surgical interventions in PD [Time frame: 12 months]
  • PART I/B: Safety measures for surgical interventions in PD [Time frame: 12 months]
  • PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD [Time frame: 12 months]
  • PART I/A: Safety measures for surgical interventions in PD [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

Please refer to main study (STIMPulseControl KKS-313)

Exclusion criteria

Please refer to main study (STIMPulseControl KKS-313)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Germany · 9 centers
  • University Hospital Cologne — Cologne
  • University Hospital Carl Gustav Carus — Dresden
  • University Hospital Duesseldorf — Düsseldorf
  • University Medical Center Hamburg-Eppendorf — Hamburg
  • University Hospital Schleswig-Holstein (UKSH), Campus Kiel — Kiel
  • University Hospital of Giessen and Marburg (UKGM), Campus Marburg — Marburg
  • Charité Campus Mitte — Mitte
  • University Hospital Tuebingen — Tübingen
  • … and 1 more center
Switzerland · 2 centers
  • University Hospital of Bern (Inselspital) — Bern
  • University Hospital Zuerich (USZ) — Zurich
Netherlands · 1 center
  • Amsterdam University Medical Center — Amsterdam

Identifiers

NCT: NCT06561919 · KKS-313-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗