Closed Loop DBS Implanted RC+S Study

The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) with two goals:

1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and 2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.

The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.

The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.

In a separate cohort, we are enrolling healthy volunteers as blinded raters of audio recordings made by people with Parkinson's disease and without Parkinson's disease to study whether different features of speech patterns are specific to PD and whether there are measurable differences in these speech features when PD participants are on different deep brain stimulation settings. These ratings do not contribute to the primary or secondary endpoints of this study.

Study design details listed in this record are specific to the Implanted RC+S clinical trial cohort.

• Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant. [Time frame: baseline and 12 months after IPG implant]
• Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant. [Time frame: baseline and 24 months after IPG implant]
• Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant. [Time frame: baseline and 48 months after IPG implant]
• Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant. [Time frame: baseline and 72 months after IPG implant]
• Change in percentage of waking hours with good "on" time at 12 months after IPG implant. [Time frame: baseline and 12 months after IPG implant]
• Change in percentage of waking hours with good "on" time at 24 months after IPG implant. [Time frame: baseline and 24 months after IPG implant]
• Change in percentage of waking hours with good "on" time at 48 months after IPG implant. [Time frame: baseline and 48 months after IPG implant]
• Change in percentage of waking hours with good "on" time at 72 months after IPG implant. [Time frame: baseline and 72 months after IPG implant]
• Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant. [Time frame: baseline and 12 months after IPG implant]
• Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant. [Time frame: baseline and 24 months after IPG implant]
• Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant. [Time frame: baseline and 48 months after IPG implant]
• Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant. [Time frame: baseline and 72 months after IPG implant]