Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD) — 12 months
Difference of change (improvement) from baseline to follow-up between the two treatment groups with respect to the hyperdopaminergic sub-score
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Cologne | Cologne | Germany | Recruiting |
| University Hospital Carl Gustav Carus | Dresden | Germany | Recruiting |
| University Hospital Duesseldorf | Düsseldorf | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Paracelsus-Elena Klinik | Kassel | Germany | Not Yet Recruiting |
| University Hospital Schleswig-Holstein (UKSH), Campus Kiel | Kiel | Germany | Recruiting |
| University Hospital of Giessen and Marburg (UKGM), Campus Marburg | Marburg | Germany | Recruiting |
| Charité Campus Mitte | Mitte | Germany | Recruiting |
| University Hospital Tuebingen | Tübingen | Germany | Recruiting |
| University Hospital Wuerzburg | Würzburg | Germany | Recruiting |
| Amsterdam University Medical Center | Amsterdam | Netherlands | Recruiting |
| University Hospital of Bern (Inselspital) | Bern | Switzerland | Recruiting |
| University Hospital Zuerich (USZ) | Zurich | Switzerland | Recruiting |
More University of Kiel trials in Germany
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06498349 on ClinicalTrials.gov ↗ ← All trials in Germany