Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
- Conditions
- Parkinson DiseaseImpulse Control Disorders
- Interventions
- Procedure: bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
- Registration Number
- NCT06498349
- Lead Sponsor
- University of Kiel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age at the time of enrollment: ≤ 70 years
- Duration of idiopathic Parkinson's disease ≥ 4 years diagnosis of PD acc. MDS clinical diagnostic criteria
- 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
- MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test
- MoCA ≥ 24 in the meds on condition
- 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.
- Patients able to understand the study requirements and the treatment procedures
- Written informed consent before any study-specific tests or procedures are performed
- Surgical contraindications to undergo DBS operation
- Ongoing severe depression (BDI-II > 28) or depression of any severity with suicidal ideation item 9 of BDI-II > 1
- Dementia (MoCA < 24) in the meds on condition
- Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
- Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
- Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
- Any history of recurrent seizures or haemorrhagic stroke
- Fertile women not using adequate contraceptive methods
- Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- Any impairment that would limit subject's ability to participate in the study and perform study procedures
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DBS-group bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic nucleus combined with best medical treatment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Starkstein-Apathy-Scale (SAS) 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
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
Hospital Anxiety and Depression Scale (HADS) 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
Beck Depression Inventory (BDI) 12 months Difference of change (improvement) from baseline to follow-up between the two treatment groups
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
Marconi Dyskinesia Rating Scale 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
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
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.
Montreal Cognitive Assessment (MoCA) 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
Trial Locations
- Locations (12)
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