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

José M. Menchón*, Eva Real, Pino Alonso, Marco Alberto Aparicio, Cinto Segalas, Gerard Plans, Laura Luyten, Els Brunfaut, Laurean Matthijs, Simon Raymakers, Chris Bervoets, Antonio Higueras, Majed Katati, José Guerrero, Mariena Hurtado, Mercedes Prieto, Lennart H. Stieglitz, Georg Löffelholz, Sebastian Walther, Claudio PolloBartosz Zurowski, Volker Tronnier, Andreas Kordon, Orsola Gambini, Rebecca Ranieri, Angelo Franzini, Giuseppe Messina, Diana Radu-Djurfeldt, Gaston Schechtmann, Long Long Chen, Renana Eitan, Zvi Israel, Hagai Bergman, Tim Brelje, Thomas C. Brionne, Aurélie Conseil, Frans Gielen, Michael Schuepbach, Bart Nuttin, Loes Gabriëls

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

49 Scopus citations

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.

Original languageAmerican English
Pages (from-to)1234-1247
Number of pages14
JournalMolecular Psychiatry
Volume26
Issue number4
DOIs
StatePublished - Apr 2021
Externally publishedYes

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Publisher Copyright:
© 2019, The Author(s).

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