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Title: A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder
Author: Menchón Magriñá, José Manuel
Real, Eva
Alonso, Pino
Aparicio, Marco Alberto
Segalàs Cosi, Cinto
Plans, Gerard
Luyten, Laura
Brunfaut, Els
Matthijs, Laurean
Raymakers, Simon
Bervoets, Chris
Higueras, Antonio
Katati, Majed
Guerrero, José
Hurtado, Mariena
Prieto, Mercedes
Stieglitz, Lennart H.
Löffelholz, Georg
Walther, Sebastian
Pollo, Claudio
Zurowski, Bartosz
Tronnier, Volker
Kordon, Andreas
Gambini, Orsola
Ranieri, Rebecca
Franzini, Angelo
Messina, Giuseppe
Radu Djurfeldt, Diana
Schechtmann, Gaston
Chen, Long-Long
Eitan, Renata
Israel, Zvi
Bergman, Hagai
Brelje, Tim
Brionne, Thomas C.
Conseil, Aurélie
Gielen, Frans
Schuepbach, Michael
Nuttin, Bart
Gabriëls, Loes
Keywords: Neurosi obsessiva
Estimulació del cervell
Seguretat dels pacients
Obsessive-compulsive disorder
Brain stimulation
Patients safety
Issue Date: 29-Oct-2019
Publisher: Nature Publishing Group
Abstract: 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.
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It is part of: Molecular Psychiatry, 2019, vol. 26, p. 1234-1247
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ISSN: 1359-4184
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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