MEDTRONIC DBS THERAPY FOR OBSESSIVE-COMPULSIVE DISORDER*

TREATING THE SYMPTOMS OF OCD WITH DBS

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. Best results are achieved when the patient and caregiver are fully informed about the therapy risks and probable benefits, surgical procedures, follow-up requirements, and self-care responsibilities.

PROBABLE BENEFITS OF MEDTRONIC DBS

  • Reduces symptom severity as defined by the clinical rating scale Yale-Brown Obsessive Compulsive Scale (YBOCS)
  • Offers the first safe† access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation
  • Allows therapy to be turned off or reversed, preserving options for future therapies and treatments

Clinical studies have been performed at three sites in the United States and one site in Europe, demonstrating the probable benefit of Medtronic DSB therapy for OCD* in treating obsessive-compulsive disorder.  See clinical summary below at manuals.medtronic.com by searching for manual document number M947128A001.

IS YOUR PATIENT A CANDIDATE FOR DBS THERAPY?

Deep brain stimulation may be considered for patients who meet the following criteria:

  • Have a diagnosis of OCD with a documented duration of at least 5 years
  • Have OCD rated as severe or chronic extreme illness
  • Have a YBOCS score of greater than or equal to 30
  • Have comorbid depression and anxiety
  • Have failed to improve following treatment with at least three selective serotonin reuptake inhibitors (SSRIs) with augmentation
  • Do not have hoarding as their primary subclassification
  • Have completed or tried to complete Cognitive Behavior Therapy (CBT)
  • Have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality disorder) or substance abuse issues
  • Meet established criteria for implantation of a deep brain stimulation system
  • Are 18 years old or older
  • Have not had a previous surgery to destroy the region of the brain that will be the target of stimulation
  • Are not pregnant
  • Have no other neurological disorders, including dementia
  • Do not have a bleeding disorder or are not taking blood thinners

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended.

Stimulation parameters should be adjusted such that maximal symptom improvement is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher stimulation parameters, which may result in possible excessive charge density. Refer to the Information for Prescribers Addendum for OCD for more information about excessive charge density.

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CONTACT MEDTRONIC

Reach U.S. Clinician Services for Medtronic DBS products at:

800-328-0810

*

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 at www.medtronic.com/mri or contact Medtronic at (1-800) 328-0810 for a complete list of conditions. Also review current MRI manufacturer labeling before conducting the MRI.