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

NCT06498349 | Recruiting DMC

• 1 other identifier: KKS-313
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 12

Brief 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

Impulse Control Disorders; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD)

  Difference of change (improvement) from baseline to follow-up between the two treatment groups with respect to the hyperdopaminergic sub-score

  12 months

Secondary Outcomes (20)

• Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS)

  12 months

• Starkstein-Apathy-Scale (SAS)

  12 months

• Hospital Anxiety and Depression Scale (HADS)

  12 months

• Beck Depression Inventory (BDI)

  12 months

• suicidal item 9 of the BDI

  12 months

Study Arms (2)

DBS-group

OTHER

Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment

Procedure: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment; 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

BMT-group

OTHER

Within indication and clinical routine: best medical treatment

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

Interventions

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 DRUG

according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.

BMT-group; DBS-group

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

according to widely accepted expert consensus paper

Also known as: best medical treatment for management of impulse control in Parkinson´s disease

DBS-group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: ≤ 70 years
• Diagnosis of PD according to MDS clinical diagnostic criteria
• Onset of first PD motor symptoms ≥ 4 years
• Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use
• MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
• Adaptation of medical therapy has been attempted
• MoCA ≥ 24 in the meds on condition
• BDI-II score \< 20 in the meds on condition, or Patients with moderately severe depression with a BDI-II between 20 and 28 points, strict consideration must be made with the involvement of a psychiatrist. Patients must be willing and able to comply this.
• Patients able to understand the study requirements and the treatment procedures
• Written informed consent before any study-specific tests or procedures are performed

You may not qualify if:

• Surgical contraindications to undergo DBS operation
• Ongoing severe depression (BDI-II \> 28)
• suicidal ideation (item 9 of BDI-II \> 1)
• Dementia (MoCA \< 24) in the meds on condition
• Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
• Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
• Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
• Any history of recurrent seizures or haemorrhagic stroke
• Fertile women not using adequate contraceptive methods
• Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
• Any impairment that would limit subject's ability to participate in the study and perform study procedures
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints

Sponsors & Collaborators

• Czech Technical University in Prague: collaborator
• University of Pennsylvania: collaborator
• University of Kiel: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator
• Philipps University Marburg: collaborator
• University Hospital Schleswig-Holstein: collaborator

Study Sites (12)

University Hospital Cologne

Cologne, Germany

RECRUITING

University Hospital Carl Gustav Carus

Dresden, Germany

RECRUITING

University Hospital Duesseldorf

Düsseldorf, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

University Hospital Schleswig-Holstein (UKSH), Campus Kiel

Kiel, Germany

RECRUITING

University Hospital of Giessen and Marburg (UKGM), Campus Marburg

Marburg, Germany

RECRUITING

Charité Campus Mitte

Mitte, Germany

RECRUITING

University Hospital Tuebingen

Tübingen, Germany

RECRUITING

University Hospital Wuerzburg

Würzburg, Germany

RECRUITING

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

University Hospital of Bern (Inselspital)

Bern, Switzerland

RECRUITING

University Hospital Zuerich (USZ)

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Ines Deboves, MD

  University Hospital Bern, Inselspital, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Paul Krack, Prof.

  University Hospital Bern, Inselspital, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Annabel van der Weide, MD

  Amsterdam University Medical Center (UMC)

  PRINCIPAL INVESTIGATOR

• Rob MA De Bie, Prof.

  Amsterdam University Medical Center (UMC)

  PRINCIPAL INVESTIGATOR

• Daniel Weintraub, Prof.

  University of Pennsylvania, Section of Geriatric Psychiatry Philadelphia

  STUDY CHAIR

• Jan Rusz, Prof.

  Czech Technical University Prague, Electrical Engineering

  STUDY CHAIR

• Ann-Kristin Helmers, Prof.

  University Hospital Kiel,UKSH, Campus Kiel, Department of Neurosurgery

  STUDY CHAIR

• Claudio Pollo, Prof.

  University Hospital Bern, Inselspital, Department of Neurology

  STUDY CHAIR

• Rick Schuurmann, Prof.

  Amsterdam University Medical Center (UMC)

  STUDY CHAIR

• Jörn Rau

  Philipps-University Marburg, Coordinating Center for Clinical (KKS)

  STUDY DIRECTOR

• Carmen Schade-Brittinger

  Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)

  STUDY DIRECTOR

• Kerstin Winterstein

  Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)

  STUDY DIRECTOR

Central Study Contacts

Steffen Paschen, MD

CONTACT

+49 (0)431 500; steffen.paschen@uksh.de

Guenther Deuschl, Prof.

CONTACT

g.deuschl@neurologie.uni-kiel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Model Details: Better personalized therapy adaptation and care for patients with behavioral disorders is possible. This is often currently not possible in routine clinical practice. The scale for primary outcome used as the main target has been tested for use and is suitable for the study purpose of monitoring ICD. We now want to examine what patients with ICD benefit most from.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 12, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); NL (1); DE (9)