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

Last updated: April 23, 2025
Sponsor: University of Kiel
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kleptomania

Mood Disorders

Treatment

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

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

Clinical Study ID

NCT06498349
KKS-313
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age at the time of enrollment: ≤ 70 years

  2. Duration of idiopathic Parkinson's disease ≥ 4 years diagnosis of PD acc. MDSclinical diagnostic criteria

  3. Moderate or severe impulse control disorder or related behavioral disordersaccording 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 thefollowing items considered to reflect ICBDs or related behaviors: pathologicalgambling, hypersexuality, shopping, eating, hobbyism, punding and compulsivemedication use

  4. MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test

  5. MoCA ≥ 24 in the meds on condition

  6. BDI-II score < 20 in the meds on condition, or Patients with moderately severedepression with a BDI-II between 20 and 28 points, strict consideration must be madewith the involvement of a psychiatrist. Patients must be willing and able to complythis.

  7. Patients able to understand the study requirements and the treatment procedures

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

Exclusion

Exclusion Criteria:

  1. Surgical contraindications to undergo DBS operation

  2. Ongoing severe depression (BDI-II > 28) or depression of any severity with suicidalideation item 9 of BDI-II > 1

  3. Dementia (MoCA < 24) in the meds on condition

  4. Any prior movement disorder treatments that involved intracranial surgery/ablationor intracranial device implantation

  5. Any other active implanted device that is likely to interfere with the implantationor functioning of the DBS system

  6. Simultaneous participation in another clinical trial targeting or potentiallyinterfering with ICD

  7. Any history of recurrent seizures or haemorrhagic stroke

  8. Fertile women not using adequate contraceptive methods

  9. Any terminal illness with significantly reduced life expectancy which exclude DBSimplantation according to standard clinical care

  10. A female who is breastfeeding or of child-bearing potential with a positive urinepregnancy test or not using adequate contraception

  11. Any impairment that would limit subject's ability to participate in the study andperform study procedures

  12. Have any significant medical condition that is likely to interfere with studyprocedures or likely to confound evaluation of study endpoints

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
Phase:
Study Start date:
September 05, 2024
Estimated Completion Date:
July 15, 2028

Connect with a study center

  • Charité Campus Mitte

    Berlin-Mitte,
    Germany

    Active - Recruiting

  • University Hospital Carl Gustav Carus

    Dresden,
    Germany

    Active - Recruiting

  • University Hospital Duesseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • University Hospital Schleswig-Holstein (UKSH), Campus Kiel

    Kiel,
    Germany

    Active - Recruiting

  • University Hospital Cologne

    Köln,
    Germany

    Active - Recruiting

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

    Marburg,
    Germany

    Active - Recruiting

  • University Hospital Tuebingen

    Tübingen,
    Germany

    Site Not Available

  • University Hospital Wuerzburg

    Würzburg,
    Germany

    Active - Recruiting

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • University Hospital of Bern (Inselspital)

    Bern,
    Switzerland

    Site Not Available

  • University Hospital Zuerich (USZ)

    Zürich,
    Switzerland

    Site Not Available

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