Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Kiel
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age at the time of enrollment: ≤ 70 years
Diagnosis of PD according to MDS clinical diagnostic criteria
Onset of first PD motor symptoms ≥ 4 years
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
Disqualifiers
Surgical contraindications to undergo DBS operation
Ongoing severe depression (BDI-II > 28)
suicidal ideation (item 9 of BDI-II > 1)
Dementia (MoCA < 24) in the meds on condition
Trial design
Design model
Parallel
Treatments tested in this trial
bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
Procedure/Surgeryaccording to widely accepted expert consensus paper
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
Drugaccording to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: DBS-groupOther 2 interventions
Group B: BMT-groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 monthsSecondary outcomes
1
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
Time frame
12 months2
Starkstein-Apathy-Scale (SAS)
Difference of change (improvement) from baseline to follow-up between the two treatment groups
Time frame
12 months3
Hospital Anxiety and Depression Scale (HADS)
Difference of change (improvement) from baseline to follow-up between the two treatment groups
Time frame
12 months4
Beck Depression Inventory (BDI)
Difference of change (improvement) from baseline to follow-up between the two treatment groups
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kiel
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborator
Philipps University Marburg
Collaborator
University Hospital Schleswig-Holstein
Collaborator
Czech Technical University in Prague
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov