impulse control disorders Parkinson's disease
Conditions
Interventions
Bilateral high-frequency deep brain stimulation of the subthalamic nucleus 
combined with best medical treatment.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age at time of enrolment =4 years of PD according to MDS clinical diagnostic criteria; 3. Moderate or severe impulse control disorders 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 Behavior scale with the following items considered to reflect ICBDs: pathological gambling, hypersexuality, shopping, eating, hobbysim, punding, and compulsive medicatie use; 4. There has been an attempt to reduce dopamine agonists with insufficient results; 5. MDS-UPDRS III improvement of >=30% in the standardized levodopa test; 6. MoCa >=24 in the ONmed condition; 7. BDI-II score
Exclusion criteria
Exclusion criteria: 1. Surgical contraindications to undergo DBS operation; 2. Ongoing severe depression (BDI-II >28)); 3. Suicidal ideation (item 9 of BDI-II>1); 4. Dementia (MoCA <24) in the ONmed condition; 5. Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation; 6. Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system; 7. Simultaneous participation in another clinical trial targeting or potentially interfering with ICD; 8. Any history of recurrent seizures or hemorrhagic stroke; 9. Fertile women not using adequate contraceptive methods; 10. Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care; 11. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception; 12. Any impairment that would limit subject*s ability to participate in the study and perform study procedures; 13. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change from baseline to 12-month follow-up in the hyperdopaminergic sub-score on the Ardouin Scale for Behavior between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in change from baseline to 12-month follow-up between the two groups in: - Quality of life (PDQ-39) - MDS-UPDRS I-IV - Dyskinesias (Marconi dyskinesia rating scale) - Beck Depression Inventory - Starkstein Apathy Scale - Neuropsychiatric Fluctuations Scale - Young Mania Rating Scale - Pittsburgh Sleep Quality Index - Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease rating scale - Clinician's global impression - Patient's global impression - Zarit Burden Interview - Levodopa equivalent dose (LED) - BMI - MoCA - Adverse events | — |
Countries
Germany, Netherlands, Switzerland
Contacts
Public ContactR.M.A. Bie
Amsterdam UMC
Outcome results
None listed