Actively Recruiting
Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Led by University of Kiel · Updated on 2026-01-05
60
Participants Needed
12
Research Sites
201 weeks
Total Duration
On this page
Sponsors
U
University of Kiel
Lead Sponsor
I
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or younger at enrollment
- Diagnosis of Parkinson's disease by MDS clinical criteria
- At least 4 years since first Parkinson's motor symptoms
- Moderate or severe impulse control disorder or related behavioral disorders with specific scores on the Ardouin behaviour scale
- Improvement of 30% or more on MDS-UPDRS III in a standardized levodopa test or presence of classical Parkinsonian tremor at rest
- Medical therapy adjustment has been attempted
- Montreal Cognitive Assessment (MoCA) score of 24 or higher on medication
- Beck Depression Inventory II (BDI-II) score less than 20 on medication, or 20-28 with psychiatrist involvement
- Ability to understand study and treatment procedures
- Written informed consent provided
You will not qualify if you...
- Surgical contraindications for DBS operation
- Severe ongoing depression (BDI-II score above 28)
- Suicidal thoughts (BDI-II item 9 score above 1)
- Dementia (MoCA score below 24) on medication
- Prior intracranial surgery or device implantation for movement disorders
- Presence of other implanted devices that could interfere with DBS
- Participation in other clinical trials targeting impulse control disorders
- History of recurrent seizures or hemorrhagic stroke
- Fertile women not using adequate contraception
- Terminal illness reducing life expectancy and excluding DBS
- Breastfeeding women or women of childbearing potential with positive pregnancy test or no contraception
- Any impairment limiting study participation or procedures
- Significant medical conditions that could interfere with study or confound results
AI-Screening
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Trial Site Locations
Total: 12 locations
1
University Hospital Cologne
Cologne, Germany
Actively Recruiting
2
University Hospital Carl Gustav Carus
Dresden, Germany
Actively Recruiting
3
University Hospital Duesseldorf
Düsseldorf, Germany
Actively Recruiting
4
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
5
University Hospital Schleswig-Holstein (UKSH), Campus Kiel
Kiel, Germany
Actively Recruiting
6
University Hospital of Giessen and Marburg (UKGM), Campus Marburg
Marburg, Germany
Actively Recruiting
7
Charité Campus Mitte
Mitte, Germany
Actively Recruiting
8
University Hospital Tuebingen
Tübingen, Germany
Actively Recruiting
9
University Hospital Wuerzburg
Würzburg, Germany
Actively Recruiting
10
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
11
University Hospital of Bern (Inselspital)
Bern, Switzerland
Actively Recruiting
12
University Hospital Zuerich (USZ)
Zurich, Switzerland
Actively Recruiting
Research Team
S
Steffen Paschen, MD
CONTACT
G
Guenther Deuschl, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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