A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder

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, interventi...

Descripción completa

Detalles Bibliográficos
Autores: 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/176452
Acceso en línea:https://hdl.handle.net/2445/176452
Access Level:acceso abierto
Palabra clave:Neurosi obsessiva
Estimulació del cervell
Seguretat dels pacients
Obsessive-compulsive disorder
Brain stimulation
Patients safety
Descripción
Sumario: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.

Similares en LA Referencia