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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Impulse Control Disorders
• Intervention / 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steffen Paschen, MD; Phone Number: 23819 +49 (0)431 500; Email: steffen.paschen@uksh.de
• Study Contact Backup: Name: Guenther Deuschl, Prof.; Email: g.deuschl@neurologie.uni-kiel.de

Study Locations

• Germany
  • Cologne, Germany
    • Recruiting
    • University Hospital Cologne
    • Contact: Michael Barbe, MD
    • Contact: Veerle Visser-Vandewalle, Prof.
  • Dresden, Germany
    • Recruiting
    • University Hospital Carl Gustav Carus
    • Contact: Bjoern Falkenburger, Prof.
  • Düsseldorf, Germany
    • Recruiting
    • University Hospital Duesseldorf
    • Contact: Alfons Schnitzler, Prof.
    • Contact: Jan Vesper, Prof.
  • Hamburg, Germany
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Monika Poetter-Nerger, MD
  • Kiel, Germany
    • Recruiting
    • University Hospital Schleswig-Holstein (UKSH), Campus Kiel
    • Contact: Steffen Paschen, MD
    • Contact: Guenter Deuschl, Prof.
  • Marburg, Germany
    • Recruiting
    • University Hospital of Giessen and Marburg (UKGM), Campus Marburg
    • Contact: David Pedrosa, MD
  • Mitte, Germany
    • Recruiting
    • Charite Campus Mitte
    • Contact: Andrea Kühn, Prof.
    • Contact: Patricia Krause, MD
  • Tübingen, Germany
    • Recruiting
    • University Hospital Tuebingen
    • Contact: Daniel Weiss, Prof.
  • Würzburg, Germany
    • Recruiting
    • University Hospital Wuerzburg
    • Contact: Philipp Carpetian, MD
    • Contact: Jens Volkmann, Prof.
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Center
    • Contact: Rob MA De Bie, Prof.
    • Contact: Annabel von der Weide, MD
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • University Hospital of Bern (Inselspital)
    • Contact: Ines Deboves, MD
    • Contact: Paul Krack, Prof.
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zuerich (USZ)
    • Contact: Lennart Stieglitz, Prof.
    • Contact: Fabian Buechele, MD
    • Sub-Investigator: Sujitha Mahendran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age at the time of enrollment: ≤ 70 years
2. Diagnosis of PD according to MDS clinical diagnostic criteria
3. Onset of first PD motor symptoms ≥ 4 years
4. 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
5. MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
6. Adaptation of medical therapy has been attempted
7. MoCA ≥ 24 in the meds on condition
8. 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.
9. Patients able to understand the study requirements and the treatment procedures

10. Written informed consent before any study-specific tests or procedures are performed

    Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DBS-group; 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; according to widely accepted expert consensus paper; Other Names: best medical treatment for management of impulse control in Parkinson´s disease; 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.
Other: BMT-group; 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; according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Starkstein-Apathy-Scale (SAS)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Hospital Anxiety and Depression Scale (HADS)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Beck Depression Inventory (BDI)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
suicidal item 9 of the BDI	safety focus on suicidal item 9 of the BDI with reference to the question for the last 2 months	12 months
Neuropsychiatric-fluctuations scale (NFS)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Young mania rating scale (YMRS)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Marconi Dyskinesia Rating Scale	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Pittsburgh Sleep Quality Index (PSQI)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Safety weight monitoring (BMI control)	Difference of change from baseline to follow-up between the two treatment groups	12 months
Montreal Cognitive Assessment (MoCA)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Clinical Global Impression (CGI-S, Severity) (CGI-C, Change)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Patient Global Impression (PGI-S, Severity) (PGI-C, Change)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment)	Difference of change (improvement) from baseline to follow-up between the two treatment groups	12 months
Adverse events	Reporting and analysis of adverse events: Frequency, type and severity of therapy related relevant adverse events of medication or DBS	12 months
Parkinson's disease Dysarthria Compound Score (PD-DCS)	An intra-group comparison will be performed between the individual patient's safety speech outcome of Parkinson's disease Dysarthria Compound Score (PD-DCS) The PD-DCS is a speech acoustic summary measure of the main speech affected domains in PD, namely monopitch, monoloudness, imprecise consonants, inappropriate silences, harsh/breathy voice, and speech timing abnormalities. Acoustic proxy measures of these perceptual speech domains can be extracted from speech using modern acoustic speech analysis.	12 months

Collaborators and Investigators

• Sponsor: University of Kiel
• Collaborators: University of Pennsylvania; University Hospital Schleswig-Holstein; Czech Technical University in Prague; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC); Insel Gruppe AG, University Hospital Bern; Philipps University Marburg
• Investigators: Principal Investigator: 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); Study Chair: 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 Director: 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 record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Dopamine; Dopamine Agonists
• Other Study ID Numbers: KKS-313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No