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

Menchón, José M; Real, Eva; Alonso, Pino; Aparicio, Marco Alberto; Segalas, 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; ... (2019). A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. (In Press). Molecular psychiatry Nature Publishing Group 10.1038/s41380-019-0562-6

[img]
Preview
Text
s41380-019-0562-6.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (3MB) | Preview

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurosurgery
04 Faculty of Medicine > University Psychiatric Services > University Hospital of Psychiatry and Psychotherapy > Translational Research Center

UniBE Contributor:

Löffelholz, Georg; Walther, Sebastian; Pollo, Claudio and Schüpbach, Michael

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1359-4184

Publisher:

Nature Publishing Group

Language:

English

Submitter:

Sebastian Walther

Date Deposited:

04 Nov 2019 14:33

Last Modified:

05 Nov 2019 07:43

Publisher DOI:

10.1038/s41380-019-0562-6

PubMed ID:

31664175

BORIS DOI:

10.7892/boris.134406

URI:

https://boris.unibe.ch/id/eprint/134406

Actions (login required)

Edit item Edit item
Provide Feedback