Objective: –

Background: Deep Brain Stimulation (DBS) is an effective therapy for Parkinson’s Disease (PD). However, it is currently applied in an open-loop fashion and symptom management relies on iterative programming. The future of this field is trending towards a closed-loop system that enables stimulation parameters to be adjusted in real-time in response to patient-specific feedback signals. Identifying reliable and robust feedback signals is a major challenge in closed-loop DBS implementation. As such, in this study, we aim to combine remote monitoring and remote programming to identify specific sensor signals that correlate with DBS programming and symptom profile changes.

Method: Ten subjects, who will undergo STN-DBS implantation for the treatment of PD with the Abbott infinity DBS system, will participate in this study. In addition to remote UPDRS, we will collect several other measures remotely, including, ESM, PDQ-8, PGIS, and a programming experience survey. In addition to survey outcomes, we will collect kinematic data from wearables, specifically a smartwatch. Remote programming will be administered using the Abbott Neurosphere Virtual Clinic platform and remote monitoring measures will be collected using the StrivePD app and PsyMate.

Results: The study is currently in data collection phase and preliminary results will be available in time for the meeting. Primary endpoints include outcomes from patient reported (PRO) and clinician reported outcome (CRO) surveys, number of remote programming sessions and compliance with remote monitoring. Clinical outcomes will also be assessed at the 6-month time point. Exploratory endpoints will focus on correlating PROs and clinical outcomes with motor fluctuations as identified from wearable data.

Conclusion: Closed-loop neuromodulation systems require technical capabilities to simultaneously record and stimulate the patient. Here, we aim to first establish the feasibility of combining these capabilities with the eventual goal of identifying robust digital biomarkers that can serve as the feedback signal for an automated system. Additionally, by enabling these capabilities (monitoring and programming) to be administered remotely, we are progressing towards alleviating the existing care access burden for our patients and steering the field towards low burden, yet objectively informed, therapy options.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/feasibility-of-combining-remote-programming-and-remote-monitoring-towards-a-closed-loop-dbs-system/