Overview
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, at the time of IPG replacement.
Description
The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up".
PD patients in need of IPG replacement will be screened for enrollment eligibility.
For the "short-term follow-up", 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). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients.
Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score < 10);
- Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
- Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
- Need to replace or reposition the leads during the IPG replacement procedure;
- Patients with > 10 recurrent falls experienced in the 3 months prior to consent;
- Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
- Patients taking less than one levodopa dose per day;
- Patients without suitable LFPs recordings or with significant artifacts;
- Pregnant or breastfeeding women.