Deep brain stimulation for impulse control disorders in Parkinson's patients
A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
This study is testing if adding deep brain stimulation to standard treatment can help Parkinson's patients with impulse control problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Kiel Academic / other |
| Locations | 12 sites (Cologne and 11 other locations) |
| Trial ID | NCT06498349 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 70 or younger with a diagnosis of Parkinson's disease for at least four years and moderate to severe impulse control disorders.
Not a fit: Patients with mild impulse control disorders or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of impulse control disorders in Parkinson's patients, enhancing their quality of life.
How similar studies have performed: Other studies have shown promising results with deep brain stimulation for various conditions, indicating potential success for this novel application in impulse control disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cologne and 11 other locations
- 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)
- University Hospital of Bern (Inselspital) — Bern, Switzerland (Recruiting)
- University Hospital Zuerich (USZ) — Zurich, Switzerland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.