A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the AlphaDBS System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
• Diagnosis of idiopathic PD;
• Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
• DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
• Patients must be able to understand and sign the informed consent document.
• Patient is ≥ 18 years old;
• Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥ 5 years;
• The disease stage is II, III or IV according to the Hoehn and Yahr scale
• Patient has history of improvement of PD-related symptoms as a direct result of levodopa intake;
• Patient has been selected for bilateral STN or GPi DBS, independently from this study, in accordance with local standard of care DBS screening;
• Patient has been selected to receive Medtronic leads model 3389 or 37086 or Abbott directional leads model number 6170 or 6172 or 6371, independently from this study, in accordance with local standard of care for DBS;
• Patient has DBS-leads circuit integrity assessed and confirmed by impedance testing, before IPG implantation;
• MoCA score \> 26 in best medical condition;
• BDI-II score \< 17 in best medical condition;
⁃ UPDRS-III improvement by ≥ 33% with levodopa challenge test (at approximately 90 min from the intake of the usual morning levodopa dose plus 30%);
⁃ Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate;
⁃ Patient has a responsible caregiver who will help completing the 3-day diary, provide feedback on activities of daily living (ADL), and ensure the patient complies with visit schedule;
⁃ Patient is on stable PD-medication for one month prior surgery;
⁃ Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits.