Clinical trial NCT06498349: Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Official title: A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Impulse Control Disorders
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
name: Philipps University Marburg
name: University Hospital Schleswig-Holstein
name: Czech Technical University in Prague
name: University of Pennsylvania
First posted: 2024-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Age at the time of enrollment: ≤ 70 years
2. Duration of idiopathic Parkinson's disease ≥ 4 years diagnosis of PD acc. MDS clinical diagnostic criteria
3. 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
4. MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test
5. MoCA ≥ 24 in the meds on condition
6. 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.
7. Patients able to understand the study requirements and the treatment procedures
8. Written informed consent before any study-specific tests or procedures are performed

   Exclusion Criteria:
9. Surgical contraindications to undergo DBS operation
10. Ongoing severe depression (BDI-II \> 28) or depression of any severity with suicidal ideation item 9 of BDI-II \> 1
11. Dementia (MoCA \< 24) in the meds on condition
12. Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
13. Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
14. Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
15. Any history of recurrent seizures or haemorrhagic stroke
16. Fertile women not using adequate contraceptive methods
17. Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
18. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
19. Any impairment that would limit subject's ability to participate in the study and perform study procedures
20. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints

Primary outcomes:
measure: Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD)
timeFrame: 12 months
Secondary outcomes:
measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS)
timeFrame: 12 months
measure: Starkstein-Apathy-Scale (SAS)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: Beck Depression Inventory (BDI)
timeFrame: 12 months
measure: suicidal item 9 of the BDI
timeFrame: 12 months
measure: Neuropsychiatric-fluctuations scale (NFS)
timeFrame: 12 months
measure: Young mania rating scale (YMRS)
timeFrame: 12 months
measure: Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index
timeFrame: 12 months
measure: Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version
timeFrame: 12 months
measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable
timeFrame: 12 months
measure: Marconi Dyskinesia Rating Scale
timeFrame: 12 months
measure: Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 months
measure: Safety weight monitoring (BMI control)
timeFrame: 12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 12 months
measure: Clinical Global Impression (CGI-S, Severity) (CGI-C, Change)
timeFrame: 12 months
measure: Patient Global Impression (PGI-S, Severity) (PGI-C, Change)
timeFrame: 12 months
measure: Parkinson's disease Dysarthria Compound Score (PD-DCS) (Speech assessment)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Parkinson's disease Dysarthria Compound Score (PD-DCS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité Campus Mitte
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: University Hospital Duesseldorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein (UKSH), Campus Kiel
city: Köln
country: Germany
facility: University Hospital Cologne
city: Marburg
country: Germany
facility: University Hospital of Giessen and Marburg (UKGM), Campus Marburg
city: Tübingen
country: Germany
facility: University Hospital Tuebingen
city: Würzburg
country: Germany
facility: University Hospital Wuerzburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Bern
country: Switzerland
facility: University Hospital of Bern (Inselspital)
city: Zürich
country: Switzerland
facility: University Hospital Zuerich (USZ)
Study officials:
affiliation: University Hospital Bern, Inselspital, Department of Neurology
name: Ines Deboves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bern, Inselspital, Department of Neurology
name: Paul Krack, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center (UMC)
name: Annabel van der Weide, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center (UMC)
name: Rob MA De Bie, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania, Section of Geriatric Psychiatry Philadelphia
name: Daniel Weintraub, Prof.
role: STUDY_CHAIR
affiliation: Czech Technical University Prague, Electrical Engineering
name: Jan Rusz, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Kiel,UKSH, Campus Kiel, Department of Neurosurgery
name: Ann-Kristin Helmers, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Bern, Inselspital, Department of Neurology
name: Claudio Pollo, Prof.
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Center (UMC)
name: Rick Schuurmann, Prof.
role: STUDY_CHAIR
affiliation: Philipps-University Marburg, Coordinating Center for Clinical (KKS)
name: Jörn Rau
role: STUDY_DIRECTOR
affiliation: Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)
name: Carmen Schade-Brittinger
role: STUDY_DIRECTOR
affiliation: Philipps-University Marburg, Coordinating Center for Clinical Trials (KKS)
name: Kerstin Winterstein
role: STUDY_DIRECTOR
References: