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Questions and Answers – DBS Therapy

Dystonia

What is Medtronic Deep Brain Stimulation (DBS) Therapy?

DBS Therapy from Medtronic offers an adjustable, reversible (by turning off or removing the system) method of treatment for dystonia.

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How does the treatment work?

DBS uses a small, pacemaker-like device, placed under the skin of the chest, to send electronic signals to an area in the brain that controls movement.

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What are the implanted components of the Medtronic DBS system?

One or two neurostimulators are needed for treatment of dystonia. The implanted components are:

  • One or two wires (leads) implanted in the brain
  • One or two extensions. Your surgeon will connect the leads to the neurostimulator using extensions that run under the skin from the chest to your neck and head
  • One or two neurostimulators, usually implanted beneath the skin in the chest below the collarbone and connected to the extension (depending on the patient, a surgeon may implant the neurostimulator in the abdomen)

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Is it possible to adjust the device settings?

The device settings and stimulation levels can be adjusted noninvasively by a clinician using a programming device.

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What probable benefits does DBS offer?

DBS Therapy for dystonia may help control your symptoms, but it is not a cure. When you turn on the brain stimulation system, it will deliver stimulation that may decrease some or all of your symptoms. Your symptoms will return when the system is turned off.

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What are the risks of DBS?

Risks of DBS can include risks of surgery, side effects, or device complications. Please refer to Risks and Probable Benefits for more information.

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What is the history of DBS?

Neurologists and neurosurgeons have used electrical stimulation since the 1960s as a way to locate and distinguish specific sites in the brain. Medtronic developed brain stimulation technology in the 1980s in conjunction with leading international physician researchers.

Medtronic DBS Therapy is currently approved to treat Parkinson's disease and essential tremor, and as a Humanitarian Device to treat dystonia and obsessive-compulsive disorder. Since 1997, more than 135,000 patients worldwide have received Medtronic DBS Therapy.

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What is a Humanitarian Use Device?

The Food and Drug Administration (FDA) approved Medtronic DBS Therapy in 2003 as a Humanitarian Use Device. A Humanitarian Use 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 dystonia and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment (effectiveness) has not been established by large clinical trials. Surgery to implant the system can only be performed in a medical center whose institutional review board has approved use of the device.


Humanitarian Device: Medtronic DBS Therapy has been authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia. The effectiveness of this device for this use has not been demonstrated. What does this mean?


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.