Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Obsessive Compulsive Disorder

Treatments: Device: Reclaim® Deep Brain Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135745

OCD PMCF Study 1.02.7003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Deep Brain Stimulation Therapy for OCD

Experimental group

Description:

Reclaim® DBS Therapy uses thin wires to deliver electric current (stimulation) to a very specific target in the brain. These wires are implanted surgically. They are attached to internal neurostimulators implanted under the skin of the chest below the collarbone, similar to cardiac pacemakers, or in the abdominal wall. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.

Treatment:

Device: Reclaim® Deep Brain Stimulation