Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl

Korábbi kezelés

• Surgical contraindications to undergo DBS operation
• Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation

Más betegség

• Dementia (MoCA < 24) in the meds on condition
• Any history of recurrent seizures or haemorrhagic stroke
• Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
• 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

Egyéb

• Ongoing severe depression (BDI-II > 28)
• suicidal ideation (item 9 of BDI-II > 1)
• 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
• Fertile women not using adequate contraceptive methods
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception

• 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