Company strategic decision

This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.

The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.

PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.

Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.

Inclusion Criteria:

• Diagnosis of idiopathic PD;
• DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%;
• Patients must be able to sign the informed consent document to participate in the clinical trial;
• Patients with a suboptimal response to DBS treatment.

Exclusion Criteria:

• Patients with severe cognitive decline (MMSE <25);
• Patients with major psychiatric issues;
• Patients with any medical condition potentially interfering with DBS battery replacement surgery;
• Patients that cannot tolerate an interruption of DBS stimulation;
• Patients taking only one levodopa dose per day;
• Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
• Pregnant or breastfeeding women.