Deep brain stimulation for impulse control disorders in Parkinson's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of bilateral deep brain stimulation (DBS) combined with best medical treatment (BMT) in patients with Parkinson's disease who also exhibit impulse control disorders. Participants will be randomly assigned to receive either DBS with BMT or BMT alone, allowing for a comparison of outcomes between the two groups. The study aims to assess behavioral changes and the management of impulse control disorders as a side effect of Parkinson's treatment. Regular clinical monitoring and assessments will be conducted throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Ines Deboves, MD — University Hospital Bern, Inselspital, Department of Neurology
• Study coordinator: Steffen Paschen, MD
• Email: steffen.paschen@uksh.de
• Phone: +49 (0)431 500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.