GA & Local Anesthesia For deep brain stimulation Have Similar Adverse Events: GALAXY Study

DBS under local anesthesia is very burdensome for all patients and holds back some who are actually good candidates for the procedure. However, it is unknown if there is a difference in outcome in asleep (general anesthesia) vs awake (local anesthesia) deep brain stimulation (DBS) of the subthalamic nucleus for advanced Parkinson disease. Therefore, researchers of the Amsterdam University Medical Centers, Amsterdam, the Netherlands, conducted a study to determine the difference in adverse effects concerning cognition, mood, and behaviour between awake and asleep DBS favouring the asleep arm of the study.

It was a single-centre prospective randomized open-label blinded endpoint clinical trial. The researchers included a total of 110 patients and randomized them to the awake group (local anesthesia; n = 56) or asleep group (general anesthesia; n = 54) for DBS surgery. They analyzed the patients from January 2016 to January 2020. The primary outcome follow-up visit was conducted 6 months after DBS. They performed bilateral subthalamic nucleus DBS while the patient was asleep in 1 study arm and awake in the other study arm. They used a frame-based intraoperative microelectrode recording technique to refine the final target placement of the DBS lead. The major outcome assessed was the between-group difference in cognitive, mood, and behavioural adverse effects as measured by a composite score. They also evaluated the Movement Disorders Society Unified Parkinson's Disease Rating Scale, the patient assessment of surgical burden and operative time.

Key findings of the study were:

• Among 110 patients, 103 patients completed 6 months follow-up.
• After 6 months of follow up, the researchers found that the proportion of patients with adverse cognitive, mood, and behavioural effects on the composite score was 15 of 52 (29%) after awake and 11 of 51 (22%) after asleep DBS (odds ratio, 0.7).
• They found no difference in improvement in the off-medication Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Examination scores between groups (mean difference, −2.0).
• However, they noted that asleep surgery was experienced as less burdensome by patients and was 26 minutes shorter than awake surgery.

The authors concluded, "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."

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DOI: 10.1001/jamaneurol.2021.2979