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

dc.rights.licenseopenen_US
dc.contributor.authorENGELHARDT, J.
dc.contributor.authorCAIRE, F.
dc.contributor.authorDAMON-PERRIERE, N.
dc.contributor.authorGUEHL, D.
dc.contributor.authorBRANCHARD, O.
dc.contributor.authorAUZOU, N.
dc.contributor.authorTISON, F.
dc.contributor.authorMEISSNER, W. G.
dc.contributor.authorKRIM, E.
dc.contributor.authorBANNIER, S.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENARD, Antoine
dc.contributor.authorSITTA, R.
dc.contributor.authorFONTAINE, D.
dc.contributor.authorHOARAU, X.
dc.contributor.authorBURBAUD, P.
dc.contributor.authorCUNY, E.
dc.date.accessioned2021-03-15T15:43:35Z
dc.date.available2021-03-15T15:43:35Z
dc.date.issued2020-11-30
dc.identifier.issn1423-0372 (Electronic) 1011-6125 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26670
dc.description.abstractEnOBJECTIVE: 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.
dc.language.isoENen_US
dc.title.enA Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease
dc.title.alternativeStereotact Funct Neurosurgen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1159/000511424en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed33254172en_US
bordeaux.journalStereotactic and Functional Neurosurgeryen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.teamUSMRen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03169821
hal.version1
hal.date.transferred2021-03-15T15:43:39Z
hal.exporttrue
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