General Anesthesia vs Local Anesthesia in Microelectrode Recording–Guided Deep-Brain Stimulation for Parkinson Disease

Abstract

IMPORTANCE It is unknown if there is a difference in outcome in asleep vs awake deep brain stimulation (DBS) of the subthalamic nucleus for advanced Parkinson disease. OBJECTIVE To determine the difference in adverse effects concerning cognition, mood, and behavior between awake and asleep DBS favoring the asleep arm of the study. DESIGN, SETTING, AND PARTICIPANTS This study was a single-center prospective randomized open-label blinded end point clinical trial. A total of 187 persons with Parkinson disease were referred for DBS between May 2015 to March 2019. Analysis took place from January 2016 to January 2020. The primary outcome follow-up visit was conducted 6 months after DBS. INTERVENTIONS Bilateral subthalamic nucleus DBS was performed while the patient was asleep (under general anesthesia) in 1 study arm and awake in the other study arm. Both arms of the study used a frame-based intraoperative microelectrode recording technique to refine final target placement of the DBS lead. MAIN OUTCOMES AND MEASURESThe primary outcome variable was the between-group difference in cognitive, mood, and behavioral adverse effects as measured by a composite score. The secondary outcomes included the Movement Disorders Society Unified Parkinson's Disease Rating Scale, the patient assessment of surgical burden and operative time.RESULTS A total of 110 patients were randomized to awake (local anesthesia; n = 56; mean [SD] age, 60.0 (7.4) years; 40 [71%] male) or to asleep (general anesthesia; n = 54; mean [SD] age, 61.3 [7.9] years; 38 [70%] male) DBS surgery. The 6-month follow-up visit was completed by 103 participants. The proportion of patients with adverse cognitive, mood, and behavioral effects on the composite score was 15 of 52 (29%) after awake and 11 of 51 (22%) after asleep DBS (odds ratio, 0.7 [95% CI, 0.3-1.7]). There was no difference in improvement in the off-medication Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Examination scores between groups (awake group: mean [SD], points; asleep group: mean [SD], points; mean difference, −2.0 [95% CI, −8.1 to 4.2]). Asleep surgery was experienced as less burdensome by patients and was 26 minutes shorter than awake surgery. CONCLUSIONS AND RELEVANCEThere was no difference in the primary outcome of asleep vs awake DBS. Future large randomized clinical trials should examine some of the newer asleep based DBS technologies because this study was limited to frame-based microelectrodeguided procedures.

Past, Present, and Future of Deep Brain Stimulation: Hardware, Software, Imaging, Physiology and Novel Approaches

“…In addition, as imaging and atlas techniques have improved, the role of MER has been called into question ( 39 ). At least one retrospective study has demonstrated no significant differences in mood between asleep and awake DBS cases, ( 44 ) but further work with larger, prospective studies are needed to truly compare the benefits of asleep vs. awake cases. Although there is some evidence that advances in interventional MRI technology has led to more accuracy regarding the anatomic placement of the DBS leads, the clinical outcomes between image-guided DBS and MER-guided DBS are similar ( 45 , 46 ).…”

Deep brain stimulation for the treatment of tremor

“…Awake DBS is typically more time consuming, more expensive, and more taxing for both the patient and the surgical team, and many centers have transitioned to asleep DBS implantation with image guidance only. While multiple studies have been published suggesting that asleep DBS outcomes are comparable to those achieved with awake DBS [59][60][61], we remain convinced that using our surgical methodology, awake DBS with intra-operative physiology and patient feedback is safer, and results in better DBS outcomes for our patients. Particularly in the treatment of tremor disorders, where intra-operative tremor suppression correlates well with post-operative tremor suppression and intra-operative adjustments can readily be made to maximize tremor suppression and minimize adverse effects of stimulation, we believe outcomes of awake DBS should be superior to those of asleep DBS, where such intraoperative evaluations and adjustments are not possible.…”

Year in Review: Synopsis of Selected Articles in Neuroanesthesia and Neurocritical Care from 2021

“…5 Holewijin et al have conducted a single-center prospective randomized open-label blinded end-point clinical trial on 110 Parkinson patients undergoing DBS. 6 The patients were randomized to GA or LA with no sedation. Their primary outcome was a composite score of cognitive, mood, and behavior adverse events at 6 months.…”