Remote Care for patients with implanted deep brain stimulation devices: Feasibility Study

INTERVENTION: Thirty‐two PD patients will be enrolled in a prospective, double‐blind study design in Australia. They will randomly be assigned to remote care paradigm (n = 16) or standard of care protocol (n = 16). For the first session, all subjects will be connected to an experienced programmer remotely via a mobile platform (programmer is off‐site) and be in the room (in‐clinic) with an expert programmer. The subject will be evaluated first by the in‐person clinician and then by the remote clinician while interacting over the mobile platform. During the programming sessions, subjects will be evaluated for PD symptoms and adjustments will be made to their programming parameters accordingly. Both clinicians (neurologist and affiliated nurse practitioner) will be unblinded to the random assignment and the clinician corresponding to the subject’s cohort will save programming parameters on to the subject’s Implantable Pulse Generator (IPG). A third assessor(in‐clinic) will determine programming effectiveness acutely (20 mins post session) and over time (3 weeks post first follow‐up programming session). Both the subject and the assessor will be blinded to whether the program is saved by the in‐person clinician or by the remote clinician. Subjects participating in this clinical investigation will be followed for 6 months (first follow‐up programming session, 3‐week assessment, 3‐month follow‐up and 6‐month follow‐up). Each session is expected to last less than an hour. At each of these sessions, subjects will be assessed for their symptoms and if needed, the clinician will make appropriate adjustments to the programming parameters. The total duration of the clinical investigation is expected to be 12 months. CONDITION: Neurological ‐ Parkinson's disease Parkinson’s Disease ; ; Parkinson’s Disease PRIMARY OUTCOME: The primary purpose of this investigation is to evaluate the safety of the remote care paradigm. This aim will be achieved by characterizing adverse events (ex: dyskinesias) within the remote care group and standard‐of‐care group within the 3‐week duration post first follow‐up programming session. Adverse events will be recorded when all subjects (both groups) return to the clinic for their 3‐week assessment. Subjects will also be asked to complete a PD motor diary to log their symptoms.[3 weeks post‐randomization.] SECONDARY OUTCOME: The secondary endpoint is the difference in UPDRS‐III scores between first follow‐up programming and 3‐week assessment.[3 weeks post‐randomization. UPDRS III will also be assessed at baseline, 3‐months and 6‐months.] INCLUSION CRITERIA: 1. Subject must provide written informed consent prior to any clinical investigation related procedure. 2. Subject will be between 21 and 75 years of age 3. Subject is diagnosed with Parkinson’s Disease 4. Subject is implanted in the subthalamic nucleus (STN) with the Abbott Infinity DBS system 5. Subject is willing to maintain a constant dose of anti‐Parkinson’s Disease medication indicated as best medical management for at least one month prior to study enrollment 6. Subject has completed at least one programming session 7. Subject is available for appropriate follow‐up times for the length of the study