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RECRUITING
NCT06498349
NA

Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl

Sponsor: University of Kiel

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-09-05

Completion Date

2028-07-15

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

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.

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