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

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

• Parkinson Disease
• Impulse Control Disorders

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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Czech Technical University in Prague

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Kiel

  lead OTHER

Principal Investigators

• Ines Deboves, MD · University Hospital Bern, Inselspital, Department of Neurology

• Paul Krack, Prof. · University Hospital Bern, Inselspital, Department of Neurology

• Annabel van der Weide, MD · Amsterdam University Medical Center (UMC)

• Rob MA De Bie, Prof. · Amsterdam University Medical Center (UMC)

• Daniel Weintraub, Prof. · University of Pennsylvania, Section of Geriatric Psychiatry Philadelphia

• Jan Rusz, Prof. · Czech Technical University Prague, Electrical Engineering

• Ann-Kristin Helmers, Prof. · University Hospital Kiel,UKSH, Campus Kiel, Department of Neurosurgery

• Claudio Pollo, Prof. · University Hospital Bern, Inselspital, Department of Neurology

• Rick Schuurmann, Prof. · Amsterdam University Medical Center (UMC)

• Jörn Rau · Philipps-University Marburg, Coordinating Center for Clinical (KKS)

• Carmen Schade-Brittinger · Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)

• Kerstin Winterstein · Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-05

Primary Completion

2027-07-15

Completion

2028-07-15

Countries

• Germany
• Netherlands
• Switzerland

Study Locations