• Stereotact Funct Neurosurg · Jan 2021

    Randomized Controlled Trial

    A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease.

    • Julien Engelhardt, François Caire, Nathalie Damon-Perrière, Dominique Guehl, Olivier Branchard, Nicolas Auzou, François Tison, Wassilios G Meissner, Elsa Krim, Stéphanie Bannier, Antoine Bénard, Rémi Sitta, Denys Fontaine, Xavier Hoarau, Pierre Burbaud, and Emmanuel Cuny.
    • CHU de Bordeaux, Service de Neurochirurgie B, Bordeaux, France, julien.engelhardt@gmail.com.
    • Stereotact Funct Neurosurg. 2021 Jan 1; 99 (3): 230-240.

    ObjectiveAsleep deep brain stimulation (DBS) for Parkinson's disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial.MethodsWe conducted a prospective, randomized, noncomparative trial to assess the motor outcomes of asleep DBS. Leads were implanted in the subthalamic nucleus (STN) according to probabilistic stereotactic coordinates with a surgical robot under O-arm© imaging guidance under either general anesthesia without microelectrode recordings (MER) (20 patients, asleep group) or local anesthesia with MER and clinical testing (9 patients, awake group).ResultsThe mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4-59.2%) in the asleep group and 47.0% (95% CI: 23.8-70.2%) in the awake group, 6 months after surgery. Except for a subcutaneous hematoma, we did not observe any complications related to the surgery. Three patients (33%) in the awake group and 8 in the asleep group (40%) had at least one side effect potentially linked with neurostimulation.ConclusionsOwing to its randomized design, our study supports the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure.© 2020 S. Karger AG, Basel.

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