Trials / Recruiting
RecruitingNCT06498349
Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Kiel · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment | according to widely accepted expert consensus paper |
| DRUG | 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. |
Timeline
- Start date
- 2024-09-05
- Primary completion
- 2027-07-15
- Completion
- 2028-07-15
- First posted
- 2024-07-12
- Last updated
- 2026-01-05
Locations
12 sites across 3 countries: Germany, Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT06498349. Inclusion in this directory is not an endorsement.