bilateral high frequency deep brai… for Parkinson's (NCT06498349)
Surgical brain stimulation reduces impulsivity
- Trial ID
- NCT06498349
- Official Title
- A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
- Goal
- Surgical brain stimulation reduces impulsivity
- 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 see whether adding deep brain stimulation to both sides of a small brain area called the subthalamic nucleus, along with carefully adjusted best medical care, can help people with Parkinson's who have pathological behavioral problems called impulse control disorders. Participants are randomly assigned to get the surgery plus coordinated medical treatment, or to receive optimized medical treatment alone, and everyone is followed during routine clinic visits with questionnaires and clinical scales. The trial is looking for adults up to 70 years old who have had Parkinson's at least four years, who have moderate to severe impulse control behaviors despite trying medication changes, who show clear improvement with levodopa on a standard test, and who have preserved thinking and not severe depression. Participants must be willing and able to give informed consent and to be randomly assigned to one of the two treatment paths.
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 see whether adding deep brain stimulation to both sides of a small brain area called the subthalamic nucleus, along with carefully adjusted best medical care, can help people with Parkinson's who have pathological behavioral problems called impulse control disorders. Participants are randomly assigned to get the surgery plus coordinated medical treatment, or to receive optimized medical treatment alone, and everyone is followed during routine clinic visits with questionnaires and clinical scales. The trial is looking for adults up to 70 years old who have had Parkinson's at least four years, who have moderate to severe impulse control behaviors despite trying medication changes, who show clear improvement with levodopa on a standard test, and who have preserved thinking and not severe depression. Participants must be willing and able to give informed consent and to be randomly assigned to one of the two treatment paths.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 10 months.
- 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.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.