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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.