Reduce impulse control disorder behaviors
- Trial ID
- NCT06498349
- Official Title
- A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
- Goal
- Reduce impulse control disorder behaviors
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Kiel
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease, Impulse Control Disorders
- Interventions
- bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment, 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
Plain-Language Summary
The goal is to reduce impulse control problems like pathological gambling, hypersexuality, compulsive shopping or eating in people with Parkinson's, while also treating levodopa‑responsive motor symptoms. The approach implants bilateral, high‑frequency deep brain stimulation electrodes into the subthalamic nucleus to deliver continuous electrical pulses that calm abnormal circuit activity; that often improves motor signs and can allow lowering dopaminergic medications that may drive impulse behaviors, and it is combined with individualized best medical treatment and medication adjustment. They are enrolling adults 18 to 70 with Parkinson's for at least 4 years who show good levodopa response or classic rest tremor, who have moderate to severe impulse control disorders despite trying medication changes, who have preserved cognition (MoCA ≥24) and no severe depression or surgical contraindications.
Locations
- 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
Frequently Asked Questions
- What is this trial testing?
- This trial is studying bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment. The goal is to reduce impulse control problems like pathological gambling, hypersexuality, compulsive shopping or eating in people with Parkinson's, while also treating levodopa‑responsive motor symptoms. The approach implants bilateral, high‑frequency deep brain stimulation electrodes into the subthalamic nucleus to deliver continuous electrical pulses that calm abnormal circuit activity; that often improves motor signs and can allow lowering dopaminergic medications that may drive impulse behaviors, and it is combined with individualized best medical treatment and medication adjustment. They are enrolling adults 18 to 70 with Parkinson's for at least 4 years who show good levodopa response or classic rest tremor, who have moderate to severe impulse control disorders despite trying medication changes, who have preserved cognition (MoCA ≥24) and no severe depression or surgical contraindications.
- Who can participate?
- Participants must be between 18 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 12 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 10 months.