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Randomized Controlled Trial
. 2021 Oct 1;78(10):1212-1219.
doi: 10.1001/jamaneurol.2021.2979.

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

Rozemarije A Holewijn  1 , Dagmar Verbaan  1 , Pepijn M van den Munckhof  1 , Maarten Bot  1 , Gert J Geurtsen  2 , Joke M Dijk  2 , Vincent J Odekerken  2 , Martijn Beudel  2 , Rob M A de Bie  2 , P Rick Schuurman  1
Affiliations
Randomized Controlled Trial

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

Rozemarije A Holewijn et al. JAMA Neurol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Drs Holewijn and Munckhof reported grants from Dutch Brain Foundation during the conduct of the study. Dr Dijk reported grants from Hersenstichting Nederland during the conduct of the study and grants from the Netherlands Organisation for Health Research and Development and Medtronic, both for the INVEST trial, outside the submitted work. Dr de Bie reported grants from Hersenstichting Charitable Organization during the conduct of the study and grants from the Netherlands Organisation for Health Research and Development, Stichting Parkinson Nederland, GE Healthcare, Medtronic, Lysosomal Therapeutics, and Neuroderm, all paid to institution, outside the submitted work. Dr Schuurman reported personal fees from Medtronic and Boston Scientific during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. CONSORT Flow Diagram
aAll 30 patients received deep brain stimulation; 26 had a preference for local anesthesia, and 4 had a preference for general anesthesia. bFive patients had previous unilateral subthalamic nucleus or bilateral globus pallidus internus deep brain stimulation, 1 patient lived abroad, and 1 patient decided against surgery. cOne patient was not eligible for deep brain stimulation and withdrew from follow-up after randomization owing to a new comorbidity. dFour patients refused to undergo neuropsychological examination after 6-month follow-up.
See this image and copyright information in PMC

References

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