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...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2019 |
| País: | España |
| Recursos: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/176452 |
| Acesso em linha: | https://hdl.handle.net/2445/176452 |
| Access Level: | acceso abierto |
| Palavra-chave: | Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
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A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorderMenchón Magriñá, José ManuelReal, EvaAlonso, PinoAparicio, Marco AlbertoSegalàs Cosi, CintoPlans, GerardLuyten, LauraBrunfaut, ElsMatthijs, LaureanRaymakers, SimonBervoets, ChrisHigueras, AntonioKatati, MajedGuerrero, JoséHurtado, MarienaPrieto, MercedesStieglitz, Lennart H.Löffelholz, GeorgWalther, SebastianPollo, ClaudioZurowski, BartoszTronnier, VolkerKordon, AndreasGambini, OrsolaRanieri, RebeccaFranzini, AngeloMessina, GiuseppeRadu Djurfeldt, DianaSchechtmann, GastonChen, Long-LongEitan, RenataIsrael, ZviBergman, HagaiBrelje, TimBrionne, Thomas C.Conseil, AurélieGielen, FransSchuepbach, MichaelNuttin, BartGabriëls, LoesNeurosi obsessivaEstimulació del cervellSeguretat dels pacientsObsessive-compulsive disorderBrain stimulationPatients safetyDeep 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 Group2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/176452Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1038/s41380-019-0562-6Molecular Psychiatry, 2019, vol. 26, p. 1234-1247https://doi.org/10.1038/s41380-019-0562-6cc by (c) Menchón Magriñá, José Manuel et al., 2019http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1764522026-05-27T06:46:51Z |
| dc.title.none.fl_str_mv |
A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| title |
A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| 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 |
| title_short |
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_sort |
A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder |
| dc.creator.none.fl_str_mv |
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 |
Menchón Magriñá, José Manuel |
| 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 |
| 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 |
| dc.subject.none.fl_str_mv |
Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| topic |
Neurosi obsessiva Estimulació del cervell Seguretat dels pacients Obsessive-compulsive disorder Brain stimulation Patients safety |
| 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. |
| publishDate |
2019 |
| dc.date.none.fl_str_mv |
2019 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/176452 |
| url |
https://hdl.handle.net/2445/176452 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: https://doi.org/10.1038/s41380-019-0562-6 Molecular Psychiatry, 2019, vol. 26, p. 1234-1247 https://doi.org/10.1038/s41380-019-0562-6 |
| dc.rights.none.fl_str_mv |
cc by (c) Menchón Magriñá, José Manuel et al., 2019 http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess |
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cc by (c) Menchón Magriñá, José Manuel et al., 2019 http://creativecommons.org/licenses/by/3.0/es/ |
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openAccess |
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application/pdf |
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Nature Publishing Group |
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Nature Publishing Group |
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Articles publicats en revistes (Ciències Clíniques) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona |
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Universidad de Barcelona |
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