PMID- 31664175
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20220531
IS  - 1476-5578 (Electronic)
IS  - 1359-4184 (Print)
IS  - 1359-4184 (Linking)
VI  - 26
IP  - 4
DP  - 2021 Apr
TI  - A prospective international multi-center study on safety and efficacy of deep 
      brain stimulation for resistant obsessive-compulsive disorder.
PG  - 1234-1247
LID - 10.1038/s41380-019-0562-6 [doi]
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.
FAU - Menchon, Jose M
AU  - Menchon JM
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain. jmenchon@bellvitgehospital.cat.
FAU - Real, Eva
AU  - Real E
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain.
FAU - Alonso, Pino
AU  - Alonso P
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain.
FAU - Aparicio, Marco Alberto
AU  - Aparicio MA
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain.
FAU - Segalas, Cinto
AU  - Segalas C
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain.
FAU - Plans, Gerard
AU  - Plans G
AD  - Bellvitge University Hospital-IDIBELL, University of Barcelona, CIBERSAM, 
      Barcelona, Spain.
FAU - Luyten, Laura
AU  - Luyten L
AUID- ORCID: 0000-0001-5380-0851
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Brunfaut, Els
AU  - Brunfaut E
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Matthijs, Laurean
AU  - Matthijs L
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Raymakers, Simon
AU  - Raymakers S
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Bervoets, Chris
AU  - Bervoets C
AUID- ORCID: 0000-0001-9842-2823
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Higueras, Antonio
AU  - Higueras A
AD  - Hospital Virgen de las Nieves, Granada, Spain.
FAU - Katati, Majed
AU  - Katati M
AD  - Hospital Virgen de las Nieves, Granada, Spain.
FAU - Guerrero, Jose
AU  - Guerrero J
AD  - Hospital Virgen de las Nieves, Granada, Spain.
FAU - Hurtado, Mariena
AU  - Hurtado M
AD  - Hospital Virgen de las Nieves, Granada, Spain.
FAU - Prieto, Mercedes
AU  - Prieto M
AD  - Hospital Virgen de las Nieves, Granada, Spain.
FAU - Stieglitz, Lennart H
AU  - Stieglitz LH
AD  - Inselspital Bern, Bern, Switzerland.
FAU - Loffelholz, Georg
AU  - Loffelholz G
AD  - Inselspital Bern, Bern, Switzerland.
FAU - Walther, Sebastian
AU  - Walther S
AD  - Inselspital Bern, Bern, Switzerland.
AD  - Translational Research Center, University Hospital of Psychiatry, Bern, 
      Switzerland.
FAU - Pollo, Claudio
AU  - Pollo C
AD  - Inselspital Bern, Bern, Switzerland.
FAU - Zurowski, Bartosz
AU  - Zurowski B
AD  - Universitatsklinik Schleswig-Holstein, Campus Lubeck, Lubeck, Germany.
FAU - Tronnier, Volker
AU  - Tronnier V
AD  - Universitatsklinik Schleswig-Holstein, Campus Lubeck, Lubeck, Germany.
FAU - Kordon, Andreas
AU  - Kordon A
AUID- ORCID: 0000-0002-1045-1994
AD  - Oberbergklinik Schwarzwald, Hornberg, and Universitatsklinikum Freiburg, Klinik 
      fur Psychiatrie und Psychotherapie, Freiburg, Germany.
FAU - Gambini, Orsola
AU  - Gambini O
AD  - Department of Health Sciences, University of Milano, San Paolo Hospital Milano, 
      Milano, Italy.
FAU - Ranieri, Rebecca
AU  - Ranieri R
AD  - Department of Health Sciences, University of Milano, San Paolo Hospital Milano, 
      Milano, Italy.
FAU - Franzini, Angelo
AU  - Franzini A
AD  - Fondazione IRCCS Istituto Naz Neurologico C.Besta, Milano, Italy.
FAU - Messina, Giuseppe
AU  - Messina G
AD  - Fondazione IRCCS Istituto Naz Neurologico C.Besta, Milano, Italy.
FAU - Radu-Djurfeldt, Diana
AU  - Radu-Djurfeldt D
AD  - Psykiatri Sydvast, OCD-departement, Karolinska University Hospital-region in 
      Huddinge, Stockholm, Sweden.
FAU - Schechtmann, Gaston
AU  - Schechtmann G
AD  - Department of Neurosurgery, Karolinska Institutet and University Hospital, 
      Stockholm, Sweden.
FAU - Chen, Long-Long
AU  - Chen LL
AD  - Department of Neurosurgery, Karolinska Institutet and University Hospital, 
      Stockholm, Sweden.
FAU - Eitan, Renana
AU  - Eitan R
AD  - Psychiatry Department, Hadassah-University Hospital, Jerusalem, Israel.
FAU - Israel, Zvi
AU  - Israel Z
AD  - Psychiatry Department, Hadassah-University Hospital, Jerusalem, Israel.
FAU - Bergman, Hagai
AU  - Bergman H
AUID- ORCID: 0000-0002-2402-6673
AD  - Psychiatry Department, Hadassah-University Hospital, Jerusalem, Israel.
FAU - Brelje, Tim
AU  - Brelje T
AD  - Medtronic, Minneapolis, USA.
FAU - Brionne, Thomas C
AU  - Brionne TC
AD  - Medtronic International Trading Sarl, Tolochenaz, Switzerland.
FAU - Conseil, Aurelie
AU  - Conseil A
AD  - Medtronic International Trading Sarl, Tolochenaz, Switzerland.
FAU - Gielen, Frans
AU  - Gielen F
AD  - Medtronic Bakken Research Center, Maastricht, The Netherlands.
FAU - Schuepbach, Michael
AU  - Schuepbach M
AD  - Inselspital Bern, Bern, Switzerland.
FAU - Nuttin, Bart
AU  - Nuttin B
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
FAU - Gabriels, Loes
AU  - Gabriels L
AD  - KU Leuven and/or UZ Leuven and/or UPC KU Leuven, Leuven, Belgium.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20191029
PL  - England
TA  - Mol Psychiatry
JT  - Molecular psychiatry
JID - 9607835
SB  - IM
MH  - Anxiety
MH  - *Deep Brain Stimulation
MH  - Humans
MH  - Internal Capsule
MH  - *Obsessive-Compulsive Disorder/therapy
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC7985042
COIS- 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 Medtronic 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.
EDAT- 2019/10/31 06:00
MHDA- 2021/05/15 06:00
PMCR- 2019/10/29
CRDT- 2019/10/31 06:00
PHST- 2017/12/28 00:00 [received]
PHST- 2019/10/12 00:00 [accepted]
PHST- 2019/09/30 00:00 [revised]
PHST- 2019/10/31 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2019/10/31 06:00 [entrez]
PHST- 2019/10/29 00:00 [pmc-release]
AID - 10.1038/s41380-019-0562-6 [pii]
AID - 562 [pii]
AID - 10.1038/s41380-019-0562-6 [doi]
PST - ppublish
SO  - Mol Psychiatry. 2021 Apr;26(4):1234-1247. doi: 10.1038/s41380-019-0562-6. Epub 
      2019 Oct 29.