Real-world Outcomes with Directional Deep Brain Stimulation (DBS) Systems: Awake versus Asleep Lead Placement

Introduction: Conducting Deep Brain Stimulation (DBS) procedures with patients asleep (i.e., under general anesthesia) has becoming increasingly
popular due to patient preference, programming flexibility with directional leads, and advances in imaging technology. Previous work assessing those undergoing awake versus asleep DBS procedures has demonstrated no difference in cognition, mood, and/or behavioral adverse effects. We compare real-world outcomes of Parkinson's disease (PD) patients using DBS systems based on patients being awake or asleep during lead placement procedures.

Methods: This is a prospective, on-label, multicenter, international real-world evaluation of subjects who received multiple-source, constant-current directional DBS systems (Boston Scientific) for treatment of PD. Based on sites' standard-of-care and preferred technique, DBS procedures were performed with subjects awake or asleep during lead placement. Subjects were followed up to 3-years post-implantation and quality-of-life and PD motor symptoms was evaluated. Endpoints evaluated at baseline and study follow-ups included Unified Parkinson's disease Rating Scale {UPDRS), MDS-UPDRS Ill {converted), Parkinson's disease Questionnaire {PDQ-39), and Global Impression of Change.

Results: Of 977 implanted patients in the study, 278 patients {mean age = 61.5±7.8 years, 64% male) were asleep during lead placement and 699 {mean age= 60.3±8.7 years, 69% male) were awake. Improvement in quality-of­-life as assessed by PDQ-39 was noted in both groups with the asleep group reporting a 4.7-point improvement and the awake group reporting a 5.0-point improvement at 1-year. Similarly, a 18.7- and 17.0-point improvement in converted MDS-UPDRS Ill scores {meds off) was noted in asleep and awake groups, respectively. Additional and updated data collected since last analysis will be provided.

Conclusion : Preliminary results show that motor function related, and quality-of-life outcomes show little to no difference between groups who received leads during DBS procedures whether awake versus asleep (i.e., under general anesthesia). Asleep DBS procedures have potential to shorten total time taken for DBS procedures.