Clinical trial NCT06561919: STIMPulseControl Ancillary Speech Study
Official title: STIMPulseControl Ancillary Speech Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Impulse Control Disorder
Keywords: Speech
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Czech Technical University in Prague
name: Insel Gruppe AG, University Hospital Bern
name: Philipps University Marburg
name: University Hospital Schleswig-Holstein
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
First posted: 2024-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)

Exclusion Criteria:

Please refer to main study (STIMPulseControl KKS-313)

Primary outcomes:
measure: Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS
timeFrame: 12 months
measure: Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD
timeFrame: 12 months
measure: Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD
timeFrame: 12 months
Secondary outcomes:
measure: PART I/B: Safety measures for surgical interventions in PD
timeFrame: 12 months
measure: PART I/B: Safety measures for surgical interventions in PD
timeFrame: 12 months
measure: PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD
timeFrame: 12 months
measure: PART I/A: Safety measures for surgical interventions in PD
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité Campus Mitte
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: University Hospital Duesseldorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein (UKSH), Campus Kiel
city: Köln
country: Germany
facility: University Hospital Cologne
city: Marburg
country: Germany
facility: University Hospital of Giessen and Marburg (UKGM), Campus Marburg
city: Tübingen
country: Germany
facility: University Hospital Tuebingen
city: Würzburg
country: Germany
facility: University Hospital Wuerzburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Bern
country: Switzerland
facility: University Hospital of Bern (Inselspital)
city: Zürich
country: Switzerland
facility: University Hospital Zuerich (USZ)
Study officials:
affiliation: Czech Technical Iniversity in Prague, Faculty of Electrical Engineering
name: Jan Rusz, Prof.
role: STUDY_CHAIR
References: