Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-05
2028-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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DBS-group
Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic necleus combined with best medical treatment
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
BMT-group
Within indication and clinical routine: best medical treatment
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Czech Technical University in Prague
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Philipps University Marburg
OTHER
University Hospital Schleswig-Holstein
OTHER
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
OTHER
Steffen Paschen
OTHER
Responsible Party
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Steffen Paschen
MD
Principal Investigators
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Jan Rusz, Prof.
Role: STUDY_CHAIR
Czech Technical Iniversity in Prague, Faculty of Electrical Engineering
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Michael Barbe, MD
Role: primary
Bjoern Falkenburger, Prof.
Role: primary
Alfons Schnitzler, Prof.
Role: primary
Monika Poetter-Nerger, MD
Role: primary
Steffen Paschen, MD
Role: primary
David Pedrosa, MD
Role: primary
Patricia Krause, MD
Role: primary
Daniel Weiss, Prof.
Role: primary
Jens Volkmann, Prof.
Role: primary
Rob MA De Bie, Prof.
Role: primary
Annabel von der Weide, MD
Role: backup
Ines Debove, MD
Role: primary
Paul Krack, Prof.
Role: backup
Lennart Stieglitz, Prof.
Role: primary
Fabian Buechele, MD
Role: backup
Other Identifiers
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KKS-313-A
Identifier Type: -
Identifier Source: org_study_id
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