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<b><i>Objective:</i></b> 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. <b><i>Methods:</i></b> 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). <b><i>Results:</i></b> 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. <b><i>Conclusions:</i></b> 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.

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Background: The control of the anatomic position of the active contacts is essential to understand the effects and adapt the settings of the neurostimulation. The localization is commonly assessed by a registration between the preoperative MRI and the postoperative CT scan. However, its accuracy depends on the quality of the registration algorithm and many software programs are available. Objective: To compare the localization of implanted deep brain stimulation (DBS) leads in the subthalamic nucleus (STN) between four registration devices. Methods: The preoperative stereotactic MRI was co-registered and fused with the 3-month postoperative CT scan in 27 patients implanted in the STN for Parkinson’s disease (53 leads). Localizations of the active contacts were calculated in the stereotactic frame space and compared between software programs. Results: The coordinates of the active contacts were different between software programs in the 3 axes (p < 0.001) with a mean vectorial error between the deepest contact locations of 1.17 mm (95% CI 1.09–1.25). Conclusion: We found a small but significant difference in the coordinates calculated on four different devices. These results have to be considered when performing studies comparing active contact locations or when following patients with an implanted DBS lead.