Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
NCT Number: NCT06498349
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Impulse Control Disorders
Interventions: PROCEDURE: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment|DRUG: best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
Sponsor: University of Kiel
Collaborators: Insel Gruppe AG, University Hospital Bern|Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)|Philipps University Marburg Medical Center|University Hospital Schleswig-Holstein, Campus Kiel|Czech Technical University in Prague|University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-31
Completion Date: 2028-07-15
Locations: Charité Campus Mitte, Berlin-Mitte, Germany|University Hospital Carl Gustav Carus, Dresden, Germany|University Hospital Duesseldorf, Düsseldorf, Germany|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany|University Hospital Cologne, Köln, Germany|University Hospital of Giessen and Marburg (UKGM), Campus Marburg, Marburg, Germany|University Hospital Tuebingen, Tübingen, Germany|University Hospital Wuerzburg, Würzburg, Germany|Amsterdam University Medical Center, Amsterdam, Netherlands|University Hospital of Bern (Inselspital), Bern, Switzerland|University Hospital Zuerich (USZ), Zürich, Switzerland

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.

Primary Outcome Measures: 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, 12 months
Secondary Outcome Measures: Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Starkstein-Apathy-Scale (SAS), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Hospital Anxiety and Depression Scale (HADS), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Beck Depression Inventory (BDI), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|suicidal item 9 of the BDI, safety focus on suicidal item 9 of the BDI with reference to the question for the last 2 months, 12 months|Neuropsychiatric-fluctuations scale (NFS), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Young mania rating scale (YMRS), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index, Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version, Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable, Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Marconi Dyskinesia Rating Scale, Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication, Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Pittsburgh Sleep Quality Index (PSQI), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Safety weight monitoring (BMI control), Difference of change from baseline to follow-up between the two treatment groups, 12 months|Montreal Cognitive Assessment (MoCA), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Clinical Global Impression (CGI-S, Severity) (CGI-C, Change), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Patient Global Impression (PGI-S, Severity) (PGI-C, Change), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment), Difference of change (improvement) from baseline to follow-up between the two treatment groups, 12 months|Adverse events, Reporting and analysis of adverse events: Frequency, type and severity of therapy related relevant adverse events of medication or DBS, 12 months|Parkinson's disease Dysarthria Compound Score (PD-DCS), 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., 12 months