RT Journal Article
T1 A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder.
A1 Menchón, José M
A1 Real, Eva
A1 Alonso, Pino
A1 Aparicio, Marco Alberto
A1 Segalas, Cinto
A1 Plans, Gerard
A1 Luyten, Laura
A1 Brunfaut, Els
A1 Matthijs, Laurean
A1 Raymakers, Simon
A1 Bervoets, Chris
A1 Higueras, Antonio
A1 Katati, Majed
A1 Guerrero, José
A1 Hurtado, Mariena
A1 Prieto, Mercedes
A1 Stieglitz, Lennart H
A1 Löffelholz, Georg
A1 Walther, Sebastian
A1 Pollo, Claudio
A1 Zurowski, Bartosz
A1 Tronnier, Volker
A1 Kordon, Andreas
A1 Gambini, Orsola
A1 Ranieri, Rebecca
A1 Franzini, Angelo
A1 Messina, Giuseppe
A1 Radu-Djurfeldt, Diana
A1 Schechtmann, Gaston
A1 Chen, Long-Long
A1 Eitan, Renana
A1 Israel, Zvi
A1 Bergman, Hagai
A1 Brelje, Tim
A1 Brionne, Thomas C
A1 Conseil, Aurélie
A1 Gielen, Frans
A1 Schuepbach, Michael
A1 Nuttin, Bart
A1 Gabriëls, Loes
AB Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS.
YR 2019
FD 2019-10-29
LK http://hdl.handle.net/10668/15544
UL http://hdl.handle.net/10668/15544
LA en
DS RISalud
RD Apr 10, 2025