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...
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| Format: | Article |
| Status: | Published version |
| Publication date: | 2019 |
| Country: | España |
| Institution: | Universidad de Barcelona |
| Repository: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/176452 |
| Online Access: | https://hdl.handle.net/2445/176452 |
| Access Level: | Open access |
| Keyword: | Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| _version_ | 1878737725982507009 |
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| author | Menchón Magriñá, José Manuel |
| author2 | 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 |
| author2_role | author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| author_browse | Alonso, Pino Aparicio, Marco Alberto Bergman, Hagai Bervoets, Chris Brelje, Tim Brionne, Thomas C. Brunfaut, Els Chen, Long-Long Conseil, Aurélie Eitan, Renata Franzini, Angelo Gabriëls, Loes Gambini, Orsola Gielen, Frans Guerrero, José Higueras, Antonio Hurtado, Mariena Israel, Zvi Katati, Majed Kordon, Andreas Luyten, Laura Löffelholz, Georg Matthijs, Laurean Menchón Magriñá, José Manuel Messina, Giuseppe Nuttin, Bart Plans, Gerard Pollo, Claudio Prieto, Mercedes Radu Djurfeldt, Diana Ranieri, Rebecca Raymakers, Simon Real, Eva Schechtmann, Gaston Schuepbach, Michael Segalàs Cosi, Cinto Stieglitz, Lennart H. Tronnier, Volker Walther, Sebastian Zurowski, Bartosz |
| author_facet | 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 |
| author_role | author |
| collection | Dipòsit Digital de la UB |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_a3fd2e80ddd0301b00f716a4d4eb3bbf |
| institution | Universidad de Barcelona |
| instname_str | Universidad de Barcelona |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:diposit.ub.edu:2445/176452 |
| publishDate | 2019 |
| publishDateSort | 2019 |
| publisher | Nature Publishing Group |
| publisherStr | Nature Publishing Group |
| reponame_str | Dipòsit Digital de la UB |
| spelling | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder 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 Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety 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. Nature Publishing Group https://hdl.handle.net/2445/176452 |
| spellingShingle | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder Menchón Magriñá, José Manuel Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| status_str | publishedVersion |
| title | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title_full | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title_fullStr | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title_full_unstemmed | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title_short | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title_sort | A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| topic | Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| topic_facet | Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| url | https://hdl.handle.net/2445/176452 |