General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial

Abstract

BackgroundThe aim of the study is to investigate if deep brain stimulation (DBS) in the subthalamic nucleus (STN) for Parkinson’s disease (PD) under general anesthesia further improves outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under local anesthesia.Methods/designThe study will be a single-center, prospective, randomized, open-label, blinded endpoint trial comparing DBS under general anesthesia with DBS under local anesthesia. The primary outcome measure is a composite score of the postoperative cognitive, mood, and behavioral adverse effects and will be measured 6 months after surgery. The secondary outcome measures consist of changes in motor symptoms, adverse effects of stimulation and surgical complications, surgical time, functional health, quality of life, patient satisfaction with the outcome of treatment, patient evaluation of the burden of therapy, and medication. A total of 110 patients with advanced PD who are candidates for DBS will be randomized during a 2.5-year period.DiscussionThe aim of this trial is to further enhance the effectiveness of DBS treatment in PD while reducing the burden of DBS surgery by studying if DBS surgery under general anesthesia results in less cognitive, mood, and behavioral adverse effects compared with surgery under local anesthesia.Trial registrationNetherlands Trial Register, NTR5809. Registered on 23 April 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2136-8) contains supplementary material, which is available to authorized users.

Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson’s Disease: A Detailed Analysis Through Literature Review

“…Therefore, the issues mentioned earlier should also be addressed in the in‐depth comparison of the efficacy of awake and asleep DBS surgeries. It is worth noting that a prospective randomized controlled trial with a large sample size to compare the outcomes of the improvement in nonmotor symptoms of PD patients through awake and asleep DBS surgeries has already been initiated . The aim of the study is to investigate if DBS in the STN for PD patients under GA can further improve outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under LA .…”

Bilateral Subthalamic Nucleus Deep Brain Stimulation under General Anesthesia: Literature Review and Single Center Experience

“…Studies published to date have shown that the rationale and technology of STN DBS surgery performed under GA are accurate, and they presented similar clinical results compared to STN DBS under LA cohort. A large-scale prospective randomized controlled trial is in progress to assess the degree of the improvement of non-motor symptoms in PD patients [120].…”

Asleep Surgery May Improve the Therapeutic Window for Deep Brain Stimulation of the Subthalamic Nucleus

“…Moreover, given the fact that TW was smaller in the awake group, clinical testing could have even had a negative impact. One has to take into account, that adequate clinical evaluation of slight changes of muscle tone, oculomotor function or speech like the differentiation between PD associated dysarthria and DBS-induced dysarthria in the operation room setting with the patient off medication for more than 12 hours can be challenging even for an experienced neurologist specialized for clinical monitoring of DBS surgery (28). Finally, the mere fact that the patient undergoes clinical testing in the awake state can already lead to placebo effects leading to better intraoperative clinical outcome that may not be confirmed postoperatively (29,30).…”