Objective: In this report, we compared real-world outcomes of Parkinson’s disease (PD) patients using Deep Brain Stimulation (DBS) Systems based on patients being awake or asleep during lead placement procedures.

Background: During the past several years, conducting 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 (1).

Method: This is a prospective, on-label, multi-center, international real-world where subjects received multiple-source, constant-current directional DBS systems (Boston Scientific) for the 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. Clinical endpoints evaluated at baseline and during study follow-up included Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS III (converted), Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of Change.

Results: A total of 633 implanted patients in the study were analyzed based on being awake or asleep during lead placement procedures. Of these, 173 patients (mean age = 61.4 ± 8.3 years, 68% male) were asleep during lead placement and 460 (mean age= 60.6 ± 8.5 years, 66% male) were awake. Improvement in quality-of-life as assessed by PDQ-39 was noted in both groups with the asleep group reporting a 5.3-point improvement (n = 111) and awake group reporting a 4.2-point improvement (n = 356) at 1-year. Similarly, a 19.1- and 21.5-point improvement in converted MDS-UPDRS III scores (meds off) was noted in the asleep and awake groups, respectively.

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 can shorten the total time taken for DBS procedures (1).  However, RCTs comparing asleep versus awake techniques are needed.

References: 1. Holewijn RA, Verbaan D, van den Munckhof PM, Bot M, Geurtsen GJ, Dijk JM, Odekerken VJ, Beudel M, de Bie RMA, Schuurman PR. General Anesthesia vs Local Anesthesia in Microelectrode Recording-Guided Deep-Brain Stimulation for Parkinson Disease: The GALAXY Randomized Clinical Trial. JAMA Neurol. 2021 Oct 1;78(10):1212-1219.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-outcomes-with-directional-deep-brain-stimulation-dbs-systems-awake-versus-asleep-lead-placement/