Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl

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.

NCT Number	NCT06498349
Lead Sponsor	University of Kiel Collaborators: Insel Gruppe AG, University Hospital Bern, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Philipps University Marburg, University Hospital Schleswig-Holstein, Czech Technical University in Prague, University of Pennsylvania
Conditions	Parkinson Disease, Impulse Control Disorders
Enrollment	60 participants
Start Date	2024-09-05
Primary Completion	2027-07-15 (estimated)
Study Completion	2028-07-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-05