Status:
RECRUITING
Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl
Lead Sponsor:
University of Kiel
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Conditions:
Parkinson Disease
Impulse Control Disorders
Eligibility:
All Genders
18-70 years
Phase:
NA
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). C...
Eligibility Criteria
Inclusion
- 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
- MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
- Adaptation of medical therapy has been attempted
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06498349
Start Date
September 5 2024
End Date
July 15 2028
Last Update
January 5 2026
Active Locations (12)
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1
University Hospital Cologne
Cologne, Germany
2
University Hospital Carl Gustav Carus
Dresden, Germany
3
University Hospital Duesseldorf
Düsseldorf, Germany
4
University Medical Center Hamburg-Eppendorf
Hamburg, Germany