Open AccessA Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson’s Disease
Author(s) -
Julien Engelhardt,
François Caire,
Nathalie Damon-Perrière,
Dominique Guehl,
Olivier Branchard,
Nicolas Auzou,
François Tison,
Wassilios G. Meissner,
E. Krim,
Stéphanie Bannier,
Antoine Bénard,
Rémi Sitta,
Denys Fontaine,
Xavier Hoarau,
Pierre Burbaud,
Emmanuel Cuny
Publication year - 2020
Publication title -
stereotactic and functional neurosurgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.798
H-Index - 63
eISSN - 1423-0372
pISSN - 1011-6125
DOI - 10.1159/000511424
Subject(s) - subthalamic nucleus , deep brain stimulation , randomized controlled trial , medicine , anesthesia , neurostimulation , parkinson's disease , surgery , psychology , stimulation , disease
Objective: Asleep 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. Methods: We 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). Results: The 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. Conclusions: Owing 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.