ABOUT THE THERAPY: OCD DEEP BRAIN STIMULATION

Treating the symptoms of obsessive-compulsive disorder

For adult patients with chronic, severe obsessive-compulsive disorder (OCD*) who do not respond well to medication or cognitive-behavior therapy, deep brain stimulation may provide some relief from the recurrent, unwanted thoughts and/or repetitive behaviors of the anxiety disorder.

Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. It works by electrically stimulating specific structures that control unwanted symptoms. For obsessive-compulsive disorder, the structure is the anterior limb of the internal capsule (AIC).

Targeted Deep Brain Stimulation Site for Obsessive-compulsive Disorder

Bilateral leads are surgically implanted in the brain and connected to one or more neurostimulators implanted near the collarbone. The neurostimulator contains a small battery and computer chip programmed to send electrical pulses to the target. The stimulation may be programmed and adjusted noninvasively by the clinician to help maximize symptom control and minimize side effects.

The probable benefit, as demonstrated in Clinical Outcomes, is considerable reduction in symptom severity as defined by the clinical rating scale YBOCS.

While DBS may treat some of the symptoms of OCD, it does not cure the underlying condition. If stimulation is discontinued, symptoms will likely return.

How It Works

Bilateral stimulation of the anterior limb of the internal capsule (AIC) is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

The power source for bilateral Reclaim™ DBS Therapy for OCD is one or two dual-program Activa™ PC neurostimulators or two single-program Activa SC neurostimulators. The power source(s) generate electrical pulses that are transmitted to the brain via two extensions and two leads. These components comprise the implantable portion of the Reclaim DBS System for bilateral OCD therapy.

A clinician programmer allows the clinician to wirelessly adjust the neurostimulator and find the level of stimulation that maximizes benefits while minimizing side effects. A patient programmer gives patients some control over their settings, within physician-prescribed limits.

MR CONDITIONAL

Medtronic gives you the first safe† access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation. Eligible patients with Medtronic DBS Therapy may have an MRI scan anywhere on the body under certain conditions. Refer to MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions and instructions for use.

ACCESS MRI RESOURCES FOR CLINICIANS

POTENTIAL RISKS

Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through the skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may also cause new or worsening neurological or psychiatric symptoms.

In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.

This therapy is not for everyone. This therapy should not be used for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and electromagnetic interference.

*

Humanitarian Device: Authorized by Federal (U.S.A.) law for use as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this device for this use has not been demonstrated.

†

Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions.