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Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Sponsor: University of Kiel
Summary
The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.
Official title: A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-09-05
Completion Date
2028-07-15
Last Updated
2026-01-05
Healthy Volunteers
No
Interventions
bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
according to widely accepted expert consensus paper
best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.
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