Impulse Control Disorders, Parkinson Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREbilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
according to widely accepted expert consensus paper
DRUGbest medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.
Sponsors
Insel Gruppe AG, University Hospital Bern
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Philipps University Marburg
University Hospital Schleswig-Holstein
Czech Technical University in Prague
University of Pennsylvania
University of Kiel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Better personalized therapy adaptation and care for patients with behavioral disorders is possible. This is often currently not possible in routine clinical practice. The scale for primary outcome used as the main target has been tested for use and is suitable for the study purpose of monitoring ICD. We now want to examine what patients with ICD benefit most from.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups with respect to the hyperdopaminergic sub-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marconi Dyskinesia Rating Scale | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Starkstein-Apathy-Scale (SAS) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Hospital Anxiety and Depression Scale (HADS) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Beck Depression Inventory (BDI) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| suicidal item 9 of the BDI | 12 months | safety focus on suicidal item 9 of the BDI with reference to the question for the last 2 months |
| Neuropsychiatric-fluctuations scale (NFS) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Young mania rating scale (YMRS) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Pittsburgh Sleep Quality Index (PSQI) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Safety weight monitoring (BMI control) | 12 months | Difference of change from baseline to follow-up between the two treatment groups |
| Montreal Cognitive Assessment (MoCA) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Clinical Global Impression (CGI-S, Severity) (CGI-C, Change) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Patient Global Impression (PGI-S, Severity) (PGI-C, Change) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment) | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
| Adverse events | 12 months | Reporting and analysis of adverse events: Frequency, type and severity of therapy related relevant adverse events of medication or DBS |
| Parkinson's disease Dysarthria Compound Score (PD-DCS) | 12 months | An intra-group comparison will be performed between the individual patient's safety speech outcome of Parkinson's disease Dysarthria Compound Score (PD-DCS) The PD-DCS is a speech acoustic summary measure of the main speech affected domains in PD, namely monopitch, monoloudness, imprecise consonants, inappropriate silences, harsh/breathy voice, and speech timing abnormalities. Acoustic proxy measures of these perceptual speech domains can be extracted from speech using modern acoustic speech analysis. |
| Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version | 12 months | Difference of change (improvement) from baseline to follow-up between the two treatment groups |
Countries
Germany, Netherlands, Switzerland
Contacts
Primary ContactSteffen Paschen, MD
Backup ContactGuenther Deuschl, Prof.
Outcome results
None listed