Clinical trial NCT01135745: Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)
Official title: Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Post-Market Clinical Follow-up Study (OCD PMCF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.

Detailed description: OCD is an anxiety disorder characterized by intrusive thoughts or images (obsessions), which increase anxiety, commonly accompanied by repetitive or ritualistic actions (compulsions), which decrease anxiety. The most frequent symptoms are contamination concerns with consequent washing or concerns about harm to self or others with consequent checking.

Although many OCD patients benefit from pharmacotherapy or CBT, between 7% and 10% of OCD patients fail to benefit from these standard treatments and may be considered treatment-resistant with a chronic deteriorating course. The most severely afflicted and disabled of these patients may be indicated for neurosurgical treatments, often considered as a therapy of last resort.

Neurosurgical procedures currently used in the treatment of severe, treatment-resistant OCD include anterior cingulotomy, subcaudate tractotomy, limbic leucotomy (which is a combination of the first two procedures) and anterior capsulotomy. The commonality between the different neurosurgical procedures is the irreversible lesioning of bilateral neuroanatomical structures and/or interconnecting pathways that are believed to be involved in the control of affect and limbic function.

An alternative neurosurgical treatment option to the standard lesioning procedures is Reclaim® Deep Brain Stimulation (DBS) Therapy for OCD, which received CE mark in July 2009.

Eligibility criteria: Inclusion Criteria:

* signing and dating of Informed Consent
* male and female patients at least 18 years of age
* diagnosis of Obsessive Compulsive Disorder
* meeting the definition of treatment resistance

Exclusion Criteria:

* Axis-I disorder primary to OCD
* contraindication to implantation
* suicide risk
* risk of non-compliance

Primary outcomes:
measure: Characterization of Adverse Events related to implant procedures, device or stimulation
timeFrame: 12 months
Secondary outcomes:
measure: To characterize improvement from baseline in OCD symptoms assessed by YBOCS.
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: Milan
country: Italy
facility: A.O. San Paolo Polo Universitario
city: Barcelona
country: Spain
facility: Hospital Ciutat Sanitaria I Universitaria de Bellvitge
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Stockholm
country: Sweden
facility: Karolinska University Hospita
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Professor of Psychiatry at UZ Leuven
name: Loes Gabriels, MD PhD MsEng
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Lübeck
name: Andreas Wahl-Kordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Freiburg
name: Ludger Tebartz van Elst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bellvitge Barcelona
name: Jose M Menchon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Granada
name: Antonio Higueras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital San Paolo Milan
name: Orsola Gambini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Michael Schüpbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry and Psychotherapy Medical University of Vienna
name: Siegried Kasper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet, Stockholm
name: Diana Radu-Djurfeldt
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah-Hebrew University and Medical Center, Jerusalem
name: Renana Eitan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.