Phase
Condition
Mood Disorders
Kleptomania
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
bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age at the time of enrollment: ≤ 70 years
Duration of idiopathic Parkinson's disease ≥ 4 years diagnosis of PD acc. MDSclinical diagnostic criteria
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
MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test
MoCA ≥ 24 in the meds on condition
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.
Patients able to understand the study requirements and the treatment procedures
Written informed consent before any study-specific tests or procedures are performed
Exclusion
Exclusion Criteria:
Surgical contraindications to undergo DBS operation
Ongoing severe depression (BDI-II > 28) or depression of any severity with suicidalideation item 9 of BDI-II > 1
Dementia (MoCA < 24) in the meds on condition
Any prior movement disorder treatments that involved intracranial surgery/ablationor intracranial device implantation
Any other active implanted device that is likely to interfere with the implantationor functioning of the DBS system
Simultaneous participation in another clinical trial targeting or potentiallyinterfering 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 DBSimplantation according to standard clinical care
A female who is breastfeeding or of child-bearing potential with a positive urinepregnancy test or not using adequate contraception
Any impairment that would limit subject's ability to participate in the study andperform study procedures
Have any significant medical condition that is likely to interfere with studyprocedures or likely to confound evaluation of study endpoints
Study Design
Connect with a study center
Charité Campus Mitte
Berlin-Mitte,
GermanySite Not Available
University Hospital Cologne
Cologne 2886242,
GermanyActive - Recruiting
University Hospital Carl Gustav Carus
Dresden,
GermanySite Not Available
University Hospital Carl Gustav Carus
Dresden 2935022,
GermanyActive - Recruiting
University Hospital Duesseldorf
Düsseldorf,
GermanySite Not Available
University Hospital Duesseldorf
Düsseldorf 2934246,
GermanyActive - Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg,
GermanySite Not Available
University Medical Center Hamburg-Eppendorf
Hamburg 2911298,
GermanyActive - Recruiting
University Hospital Schleswig-Holstein (UKSH), Campus Kiel
Kiel,
GermanySite Not Available
University Hospital Schleswig-Holstein (UKSH), Campus Kiel
Kiel 2891122,
GermanyActive - Recruiting
University Hospital Cologne
Köln,
GermanySite Not Available
University Hospital of Giessen and Marburg (UKGM), Campus Marburg
Marburg,
GermanySite Not Available
University Hospital of Giessen and Marburg (UKGM), Campus Marburg
Marburg 2873759,
GermanyActive - Recruiting
Charité Campus Mitte
Mitte 6545310,
GermanyActive - Recruiting
University Hospital Tuebingen
Tübingen,
GermanySite Not Available
University Hospital Tuebingen
Tübingen 2820860,
GermanyActive - Recruiting
University Hospital Wuerzburg
Würzburg,
GermanySite Not Available
University Hospital Wuerzburg
Würzburg 2805615,
GermanyActive - Recruiting
Amsterdam University Medical Center
Amsterdam,
NetherlandsSite Not Available
Amsterdam University Medical Center
Amsterdam 2759794,
NetherlandsActive - Recruiting
University Hospital of Bern (Inselspital)
Bern,
SwitzerlandSite Not Available
University Hospital of Bern (Inselspital)
Bern 2661552,
SwitzerlandActive - Recruiting
University Hospital Zuerich (USZ)
Zurich 2657896,
SwitzerlandActive - Recruiting
University Hospital Zuerich (USZ)
Zürich,
SwitzerlandSite Not Available

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