Subthalamic nucleus stimulation in severe obsessive-compulsive disorder.
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.)
Mallet
Luc
L
The authors' affiliations are listed in the Appendix.
Polosan
Mircea
M
Jaafari
Nematollah
N
Baup
Nicolas
N
Welter
Marie-Laure
ML
Fontaine
Denys
D
du Montcel
Sophie Tezenas
ST
Yelnik
Jérôme
J
Chéreau
Isabelle
I
Arbus
Christophe
C
Raoul
Sylvie
S
Aouizerate
Bruno
B
Damier
Philippe
P
Chabardès
Stephan
S
Czernecki
Virginie
V
Ardouin
Claire
C
Krebs
Marie-Odile
MO
Bardinet
Eric
E
Chaynes
Patrick
P
Burbaud
Pierre
P
Cornu
Philippe
P
Derost
Philippe
P
Bougerol
Thierry
T
Bataille
Benoit
B
Mattei
Vianney
V
Dormont
Didier
D
Devaux
Bertrand
B
Vérin
Marc
M
Houeto
Jean-Luc
JL
Pollak
Pierre
P
Benabid
Alim-Louis
AL
Agid
Yves
Y
Krack
Paul
P
Millet
Bruno
B
Pelissolo
Antoine
A
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