RecruitingNot ApplicableNCT06498349

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


Sponsor

University of Kiel

Enrollment

60 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (called STIMPulseControl) is testing whether deep brain stimulation (DBS) surgery — which uses implanted electrodes to regulate brain signals — can reduce compulsive behaviors (like gambling, hypersexuality, or binge eating) in people with Parkinson's disease who have developed these problems, often as a side effect of their medications. **You may be eligible if...** - You are 70 or younger and have been diagnosed with Parkinson's disease for at least 4 years - You have moderate to severe impulse control problems (like compulsive gambling, shopping, eating, or hypersexuality) as measured by a validated scale - Your Parkinson's motor symptoms are responsive to levodopa medication - Your general health and cognitive function are adequate for surgery **You may NOT be eligible if...** - You have severe dementia or major psychiatric illness that would prevent surgery - You are above 70 years of age - Your Parkinson's does not respond well to levodopa - You have other neurological conditions or implanted devices incompatible with the stimulator Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment

according to widely accepted expert consensus paper

DRUGbest 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.


Locations(12)

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

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NCT06498349


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