Objective: In this report, real-world outcomes derived from Parkinson’s disease (PD) patients using Deep Brain Stimulation (DBS) Systems who were implanted either awake or asleep are described.

Background: DBS procedures for PD and other movement disorders are typically conducted with patients awake to allow for intraoperative clinical testing and/or micro-electrode recording to confirm lead location. However, during the past several years, conducting these 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 (1-3).

Method: This is a prospective, on-label, multi-center, international observational study (NCT02071134). Subjects received their multiple-source, constant-current directional DBS systems (Boston Scientific) for treatment of PD. Based on site’s standard of care and preferred technique, DBS procedures were either performed with subjects awake or asleep during lead placement. Subjects were followed up to 3-years post-implantation where their overall improvement in 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, Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of Change.

Results: To date, 138 patients (mean age = 61.4±9.1 years, 67% male) were asleep during lead placement and 405 patients (mean age = 60.4±9.1 years, 65% male) received their implant while awake. Improvement in quality of life as assessed by PDQ-39 was noted in both groups with the asleep group reporting a 6.6-point improvement (n=77) and awake group reporting a 4.2-point improvement (n=245) at 1-year. Similarly, a 17.7- and 20.7-point improvement in MDS-UPDRS III scores (meds off) was noted in asleep and awake group respectively. No significant differences in subjects’ mental status (BDI) and cognitive status (MoCA) were noted between awake versus asleep groups at 1-year.

Conclusion: These registry results demonstrate no significant difference in outcomes among patients undergoing awake versus asleep DBS. This would offer therefore the potential for shortening the total time taken for DBS procedures, increase comfort without losing safety and precision. 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.
2. LaHue SC, Ostrem JL, Galifianakis NB, San Luciano M, Ziman N, Wang S, Racine CA, Starr PA, Larson PS, Katz M. Parkinson’s disease patient preference and experience with various methods of DBS lead placement. Parkinsonism Relat Disord. 2017 Aug;41:25-30.
3. Brodsky MA, Anderson S, Murchison C, Seier M, Wilhelm J, Vederman A, Burchiel KJ. Clinical outcomes of asleep vs awake deep brain stimulation for Parkinson disease. Neurology. 2017 Nov 7;89(19):1944-1950.

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