title: Subthalamic nucleus stimulation in severe obsessive-compulsive disorder.
abstract: BACKGROUND
  Severe, refractory obsessive-compulsive disorder (OCD) is a disabling condition. Stimulation of the subthalamic nucleus, a procedure that is already validated for the treatment of movement disorders, has been proposed as a therapeutic option.
  
  
  METHODS
  In this 10-month, crossover, double-blind, multicenter study assessing the efficacy and safety of stimulation of the subthalamic nucleus, we randomly assigned eight patients with highly refractory OCD to undergo active stimulation of the subthalamic nucleus followed by sham stimulation and eight to undergo sham stimulation followed by active stimulation. The primary outcome measure was the severity of OCD, as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), at the end of two 3-month periods. General psychopathologic findings, functioning, and tolerance were assessed with the use of standardized psychiatric scales, the Global Assessment of Functioning (GAF) scale, and neuropsychological tests.
  
  
  RESULTS
  After active stimulation of the subthalamic nucleus, the Y-BOCS score (on a scale from 0 to 40, with lower scores indicating less severe symptoms) was significantly lower than the score after sham stimulation (mean [+/-SD], 19+/-8 vs. 28+/-7; P=0.01), and the GAF score (on a scale from 1 to 90, with higher scores indicating higher levels of functioning) was significantly higher (56+/-14 vs. 43+/-8, P=0.005). The ratings of neuropsychological measures, depression, and anxiety were not modified by stimulation. There were 15 serious adverse events overall, including 1 intracerebral hemorrhage and 2 infections; there were also 23 nonserious adverse events.
  
  
  CONCLUSIONS
  These preliminary findings suggest that stimulation of the subthalamic nucleus may reduce the symptoms of severe forms of OCD but is associated with a substantial risk of serious adverse events. (ClinicalTrials.gov number, NCT00169377.)
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Luc
authors.initials: L
authors.lastname: Mallet
authors.forename: Mircea
authors.initials: M
authors.lastname: Polosan
authors.forename: Nematollah
authors.initials: N
authors.lastname: Jaafari
authors.forename: Nicolas
authors.initials: N
authors.lastname: Baup
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Welter
authors.forename: Denys
authors.initials: D
authors.lastname: Fontaine
authors.forename: Sophie Tezenas
authors.initials: ST
authors.lastname: du Montcel
authors.forename: Jérôme
authors.initials: J
authors.lastname: Yelnik
authors.forename: Isabelle
authors.initials: I
authors.lastname: Chéreau
authors.forename: Christophe
authors.initials: C
authors.lastname: Arbus
authors.forename: Sylvie
authors.initials: S
authors.lastname: Raoul
authors.forename: Bruno
authors.initials: B
authors.lastname: Aouizerate
authors.forename: Philippe
authors.initials: P
authors.lastname: Damier
authors.forename: Stephan
authors.initials: S
authors.lastname: Chabardès
authors.forename: Virginie
authors.initials: V
authors.lastname: Czernecki
authors.forename: Claire
authors.initials: C
authors.lastname: Ardouin
authors.forename: Marie-Odile
authors.initials: MO
authors.lastname: Krebs
authors.forename: Eric
authors.initials: E
authors.lastname: Bardinet
authors.forename: Patrick
authors.initials: P
authors.lastname: Chaynes
authors.forename: Pierre
authors.initials: P
authors.lastname: Burbaud
authors.forename: Philippe
authors.initials: P
authors.lastname: Cornu
authors.forename: Philippe
authors.initials: P
authors.lastname: Derost
authors.forename: Thierry
authors.initials: T
authors.lastname: Bougerol
authors.forename: Benoit
authors.initials: B
authors.lastname: Bataille
authors.forename: Vianney
authors.initials: V
authors.lastname: Mattei
authors.forename: Didier
authors.initials: D
authors.lastname: Dormont
authors.forename: Bertrand
authors.initials: B
authors.lastname: Devaux
authors.forename: Marc
authors.initials: M
authors.lastname: Vérin
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Houeto
authors.forename: Pierre
authors.initials: P
authors.lastname: Pollak
authors.forename: Alim-Louis
authors.initials: AL
authors.lastname: Benabid
authors.forename: Yves
authors.initials: Y
authors.lastname: Agid
authors.forename: Paul
authors.initials: P
authors.lastname: Krack
authors.forename: Bruno
authors.initials: B
authors.lastname: Millet
authors.forename: Antoine
authors.initials: A
authors.lastname: Pelissolo
mesh_terms: D000328:Adult; D002543:Cerebral Hemorrhage / Q000209:etiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D007239:Infections / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009771:Obsessive-Compulsive Disorder / Q000628:therapy*; D020531:Subthalamic Nucleus