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

Stereotact Funct Neurosurg. 2021;99(3):230-240. doi: 10.1159/000511424. Epub 2020 Nov 30.


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.

Trial registration: ClinicalTrials.gov NCT01817088.

Keywords: Asleep surgery; Awake surgery; Deep brain stimulation; Microelectrode recordings; Parkinson’s disease; Subthalamic nucleus.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Deep Brain Stimulation*
  • Humans
  • Imaging, Three-Dimensional
  • Parkinson Disease* / therapy
  • Prospective Studies
  • Subthalamic Nucleus*
  • Surgery, Computer-Assisted*
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Wakefulness

Associated data

  • ClinicalTrials.gov/NCT01817088