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Original Investigation
September 7, 2021

General Anesthesia vs Local Anesthesia in Microelectrode Recording–Guided Deep-Brain Stimulation for Parkinson Disease: The GALAXY Randomized Clinical Trial

Author Affiliations
  • 1Department of Neurosurgery, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands
  • 2Department of Neurology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands
JAMA Neurol. Published online September 7, 2021. doi:10.1001/jamaneurol.2021.2979
Key Points

Question  Is deep brain stimulation (DBS) surgery in Parkinson disease under general anesthesia associated with less cognitive, mood, and behavioral adverse effects than DBS under local anesthesia, while being equally effective for motor improvement?

Findings  In this single-center randomized clinical trial including 110 patients with Parkinson disease, frame-based microelectrode-guided asleep DBS was associated with similar cognitive, mood, and behavioral adverse effects compared with awake DBS. Both groups showed equal improvement in motor function; surgery under general anesthesia was faster and less burdensome.

Meaning  An asleep microelectrode-guided bilateral subthalamic nucleus DBS approach had similar outcomes to awake surgery; the incidence of cognitive, mood, and behavioral effects after surgery under local anesthesia was not higher than after general anesthesia in this cohort.

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 Measures  The 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], −27.3 [17.5] points; asleep group: mean [SD], −25.3 [14.3] 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 Relevance  There 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 microelectrode-guided procedures.

Trial Registration  trialregister.nl Identifier: NTR5809

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