Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

MedtronicNeuro32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obsessive Compulsive Disorder

Interventions

Reclaim® Deep Brain StimulationDEVICE

Implant of leads in pre-defined brain area; implant of neurostimulators

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Universitaire Ziekenhuis Leuven

Leuven, Belgium

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

A.O. San Paolo Polo Universitario

Milan, Italy

Outcomes

Primary Outcomes

Characterization of Adverse Events related to implant procedures, device or stimulation

Prior to any other study procedures Adverse Events will be assessed at every study visit, i.e. after assessment at the baseline visit this will be implant visit, first parameter selection visit and regular visits after 3, 6, and 12 months treatment. AEs will also be collected at all unscheduled visits prior to all other assessments. AEs and stimulation effects will be categorized and recorded in the patient CRF. An independent clinical event committee will review and adjudicate AEs on a regular basis throughout the study.

Time frame: 12 months

Secondary Outcomes

To characterize improvement from baseline in OCD symptoms assessed by YBOCS.

YBOCS score is taken at baseline and then at post-implant visits after 3, 6 and 12 months.

Time frame: 12 months

Data from ClinicalTrials.gov

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