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Article Dans Une Revue Stereotactic and Functional Neurosurgery Année : 2021

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

Julien Engelhardt
  • Fonction : Auteur
François Caire
  • Fonction : Auteur
Nathalie Damon-Perrière
  • Fonction : Auteur
Dominique Guehl
  • Fonction : Auteur
Olivier Branchard
  • Fonction : Auteur
Nicolas Auzou
  • Fonction : Auteur
François Tison
  • Fonction : Auteur
Wassilios Meissner
  • Fonction : Auteur
Elsa Krim
  • Fonction : Auteur
Stéphanie Bannier
  • Fonction : Auteur
Antoine Bénard
  • Fonction : Auteur
Rémi Sitta
  • Fonction : Auteur
Denys Fontaine
  • Fonction : Auteur
Xavier Hoarau
  • Fonction : Auteur
Pierre Burbaud
  • Fonction : Auteur
Emmanuel Cuny
  • Fonction : Auteur

Résumé

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.

Domaines

Neurosciences

Dates et versions

hal-04449075 , version 1 (09-02-2024)

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Citer

Julien Engelhardt, François Caire, Nathalie Damon-Perrière, Dominique Guehl, Olivier Branchard, et al.. A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson’s Disease. Stereotactic and Functional Neurosurgery, 2021, 99 (3), pp.230-240. ⟨10.1159/000511424⟩. ⟨hal-04449075⟩

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