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

University of Kiel60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Parkinson Disease Impulse Control Disorders

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (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

...and 2 more locations

Outcomes

Primary Outcomes

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

Time frame: 12 months