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 Pollo; Bartosz 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

doi:10.1038/s41380-019-0562-6

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 journal › Article › peer-review

43 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 language	American English
Pages (from-to)	1234-1247
Number of pages	14
Journal	Molecular Psychiatry
Volume	26
Issue number	4
DOIs	https://doi.org/10.1038/s41380-019-0562-6
State	Published - Apr 2021
Externally published	Yes

Bibliographical note

Funding Information:
Conflict of interest TCB, FG, and TB are employees of Medtronic and received standard salaries during the conduct of the study. LB received personal fees for study design and data collection during the conduct of the study. BN is the first author on a patent on DBS for OCD, and received grants as Chair ‘Neuromodulation, an endowment from Medtronic’ and ‘Neurosurgery for Psychiatric Disorders’, from Med-tronic during the conduct of the study. AK, MP and BZ received grants from Medtronic during the conduct of the study. RE received compensation and equipment support, MS received funding of study procedures and VT received funding of travelcosts, all them from Medtronic during the conduct of the study. Bellvitge University Hospital and Fondazione IRCCS Istituto Naz Neurologico C.Besta received partial financial support for the conduct of the study.

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

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Menchón, J. M., Real, E., Alonso, P., Aparicio, M. A., Segalas, C., Plans, G., Luyten, L., Brunfaut, E., Matthijs, L., Raymakers, S., Bervoets, C., Higueras, A., Katati, M., Guerrero, J., Hurtado, M., Prieto, M., Stieglitz, L. H., Löffelholz, G., Walther, S., ... Gabriëls, L. (2021). A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. Molecular Psychiatry, 26(4), 1234-1247. https://doi.org/10.1038/s41380-019-0562-6

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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 {\textquoteleft}programming/stimulation{\textquoteright} (in 26 patients), followed by {\textquoteleft}New illness, injury, condition{\textquoteright} (13 patients) and {\textquoteleft}pre-existing condition, worsening or exacerbation{\textquoteright} (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.",

author = "Mench{\'o}n, {Jos{\'e} M.} and Eva Real and Pino Alonso and Aparicio, {Marco Alberto} and Cinto Segalas and Gerard Plans and Laura Luyten and Els Brunfaut and Laurean Matthijs and Simon Raymakers and Chris Bervoets and Antonio Higueras and Majed Katati and Jos{\'e} Guerrero and Mariena Hurtado and Mercedes Prieto and Stieglitz, {Lennart H.} and Georg L{\"o}ffelholz and Sebastian Walther and Claudio Pollo and Bartosz Zurowski and Volker Tronnier and Andreas Kordon and Orsola Gambini and Rebecca Ranieri and Angelo Franzini and Giuseppe Messina and Diana Radu-Djurfeldt and Gaston Schechtmann and Chen, {Long Long} and Renana Eitan and Zvi Israel and Hagai Bergman and Tim Brelje and Brionne, {Thomas C.} and Aur{\'e}lie Conseil and Frans Gielen and Michael Schuepbach and Bart Nuttin and Loes Gabri{\"e}ls",

note = "Funding Information: Conflict of interest TCB, FG, and TB are employees of Medtronic and received standard salaries during the conduct of the study. LB received personal fees for study design and data collection during the conduct of the study. BN is the first author on a patent on DBS for OCD, and received grants as Chair {\textquoteleft}Neuromodulation, an endowment from Medtronic{\textquoteright} and {\textquoteleft}Neurosurgery for Psychiatric Disorders{\textquoteright}, from Med-tronic during the conduct of the study. AK, MP and BZ received grants from Medtronic during the conduct of the study. RE received compensation and equipment support, MS received funding of study procedures and VT received funding of travelcosts, all them from Medtronic during the conduct of the study. Bellvitge University Hospital and Fondazione IRCCS Istituto Naz Neurologico C.Besta received partial financial support for the conduct of the study. Publisher Copyright: {\textcopyright} 2019, The Author(s).",

year = "2021",

month = apr,

doi = "10.1038/s41380-019-0562-6",

language = "American English",

volume = "26",

pages = "1234--1247",

journal = "Molecular Psychiatry",

issn = "1359-4184",

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Menchón, JM, Real, E, Alonso, P, Aparicio, MA, Segalas, C, Plans, G, Luyten, L, Brunfaut, E, Matthijs, L, Raymakers, S, Bervoets, C, Higueras, A, Katati, M, Guerrero, J, Hurtado, M, Prieto, M, Stieglitz, LH, Löffelholz, G, Walther, S, Pollo, C, Zurowski, B, Tronnier, V, Kordon, A, Gambini, O, Ranieri, R, Franzini, A, Messina, G, Radu-Djurfeldt, D, Schechtmann, G, Chen, LL, Eitan, R, Israel, Z, Bergman, H, Brelje, T, Brionne, TC, Conseil, A, Gielen, F, Schuepbach, M, Nuttin, B & Gabriëls, L 2021, 'A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder', Molecular Psychiatry, vol. 26, no. 4, pp. 1234-1247. https://doi.org/10.1038/s41380-019-0562-6

TY - JOUR

T1 - A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder

AU - Menchón, José M.

AU - Real, Eva

AU - Alonso, Pino

AU - Aparicio, Marco Alberto

AU - Segalas, Cinto

AU - Plans, Gerard

AU - Luyten, Laura

AU - Brunfaut, Els

AU - Matthijs, Laurean

AU - Raymakers, Simon

AU - Bervoets, Chris

AU - Higueras, Antonio

AU - Katati, Majed

AU - Guerrero, José

AU - Hurtado, Mariena

AU - Prieto, Mercedes

AU - Stieglitz, Lennart H.

AU - Löffelholz, Georg

AU - Walther, Sebastian

AU - Pollo, Claudio

AU - Zurowski, Bartosz

AU - Tronnier, Volker

AU - Kordon, Andreas

AU - Gambini, Orsola

AU - Ranieri, Rebecca

AU - Franzini, Angelo

AU - Messina, Giuseppe

AU - Radu-Djurfeldt, Diana

AU - Schechtmann, Gaston

AU - Chen, Long Long

AU - Eitan, Renana

AU - Israel, Zvi

AU - Bergman, Hagai

AU - Brelje, Tim

AU - Brionne, Thomas C.

AU - Conseil, Aurélie

AU - Gielen, Frans

AU - Schuepbach, Michael

AU - Nuttin, Bart

AU - Gabriëls, Loes

N1 - Funding Information: Conflict of interest TCB, FG, and TB are employees of Medtronic and received standard salaries during the conduct of the study. LB received personal fees for study design and data collection during the conduct of the study. BN is the first author on a patent on DBS for OCD, and received grants as Chair ‘Neuromodulation, an endowment from Medtronic’ and ‘Neurosurgery for Psychiatric Disorders’, from Med-tronic during the conduct of the study. AK, MP and BZ received grants from Medtronic during the conduct of the study. RE received compensation and equipment support, MS received funding of study procedures and VT received funding of travelcosts, all them from Medtronic during the conduct of the study. Bellvitge University Hospital and Fondazione IRCCS Istituto Naz Neurologico C.Besta received partial financial support for the conduct of the study. Publisher Copyright: © 2019, The Author(s).

PY - 2021/4

Y1 - 2021/4

N2 - 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.

AB - 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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U2 - 10.1038/s41380-019-0562-6

DO - 10.1038/s41380-019-0562-6

M3 - Article

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SN - 1359-4184

VL - 26

SP - 1234

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JO - Molecular Psychiatry

JF - Molecular Psychiatry

IS - 4

ER -

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

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