Questions and Answers - Getting DBS Therapy Deep Brain Stimulation for Obsessive-Compulsive Disorder (OCD)
Reclaim DBS is not right for everyone. Only a doctor experienced with Reclaim DBS can determine whether or not you are a candidate. A prescription is required.
The Food and Drug Administration (FDA) approved Medtronic DBS Therapy in 2009 as a Humanitarian Device for OCD. A Humanitarian Device is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 new people in the United States each year.
The FDA reviewed the safety of Medtronic DBS Therapy for OCD and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment (effectiveness) has not been demonstrated. Surgery to implant the system can only be performed in a medical center whose institutional review board has approved use of the device.
Most people spend a couple of days at the hospital. Healing can take several weeks. You will have pain medications for any discomfort you may have at the incision sites.
Your clinician programs your stimulation levels wirelessly. The process is a noninvasive way of adjusting stimulation to meet your symptom control needs.
Only Medtronic provides safe† access to MRI anywhere on the body with some Medtronic DBS systems under certain conditions — giving your doctor an important tool for diagnosis. Some Medtronic DBS devices may remain on, when programmed to certain conditions, while you have an MRI. You may take comfort in knowing that the device can remain on (if programmed to the right settings) to control your symptoms. This may allow the quality of the image to be improved if the movement symptoms related to the disease are reduced.
You must inform the doctor who manages your Medtronic DBS Therapy that an MRI examination has been prescribed for you. Your doctor needs to determine what type of MRI scan you are eligible to receive. Depending on what kind of Medtronic DBS system components that you have implanted, you may be eligible for one of the following types of MRI scans:
Before your MRI appointment always read the MRI examinations section of your patient manual.
Consult your doctor before engaging in any medical treatment or diagnostic test (for example, mammograms, electrocautery, MRI, or heart defibrillation). Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), and diathermy (deep heat treatment) should not be permitted under any circumstances. Refer to Important Safety Information for more information.
The total cost varies significantly. Please contact your healthcare provider for an estimate of the costs associated with Reclaim DBS Therapy.
Coverage for Reclaim DBS Therapy is typically made on a case-by-case basis by Medicare, Medicaid and private payers. Humanitarian Use Devices are eligible for Medicare coverage if the treatment is provided by a site that has institutional review board approval. Please contact your insurance company to see if your health plan provides coverage.
Depending on your body build, the neurostimulator may be noticeable as a small bulge under the skin. It typically isn't noticeable under clothes. There also may be a slight bump on the top of your head, but it usually isn't visible under hair.
Medtronic DBS systems are MR Conditional which means they are safe for MRI scans only under certain conditions. If the conditions are not met, the MRI could cause tissue heating especially at the implanted lead(s) in the brain which may result in serious and permanent injury or death. Before having an MRI, always talk with the doctor who manages your DBS to determine your eligibility and discuss potential benefits and risks of MRI. For further information, please call Medtronic at 1-800-328-0810.
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.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.