How long will it take for the DBS Therapy to work after the implant procedure?
Typically, a Medtronic DBS Therapy system is not activated until you have healed from the surgery. Optimal results are normally achieved after the doctor or nurse who programs your device has gone through multiple programming sessions with you. This process may take several months.
Is this a new type of treatment for dystonia?
Medtronic has been providing products and therapies that alleviate pain, restore health, and extend life for over 50 years. Medtronic DBS Therapy was developed by Medtronic in the 1980s and approved for use in the United States in 1997 for essential tremor.
In April 2003, Medtronic DBS Therapy for Dystonia received Humanitarian Device Exemption approval in the United States to aid in the management of chronic primary dystonia. The effectiveness of this device for this use has not been demonstrated.
What is an HDE?
Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions affecting fewer than 4,000 new patients per year. The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Effective treatment of symptoms, however, has not been studied in formal clinical trials. Surgery to implant Medtronic DBS Therapy for Dystonia can be performed only in medical centers that specifically approve its use.
Is this a permanent procedure?
Medtronic DBS Therapy is a reversible procedure. It is also adjustable, which means that the stimulation can be adjusted to match changes in your symptoms. The system can also be deactivated or even removed. Removal would require additional surgery.
Can DBS Therapy be used in children with dystonia?
Dystonia, particularly the generalized form, often affects children.
Children 7 years of age or older can be considered candidates for Medtronic DBS Therapy. Medtronic recommends the use of DBS Therapy for individuals in whom brain growth is 90% complete (typically at age 7). In cases where growth of the brain and/or skull is not complete at the time of implant, continued grown of the skull may cause migration of the DBS Therapy lead. Children 7 and older may require additional length to the extension to allow the system to continue to function as they grow. Placing a longer extension requires another surgical procedure.
As a child grows, the doctor may need to adjust the settings of the stimulation or reprogram the electrodes that are used to deliver stimulation. These programming changes can be done during a visit to the doctor's office, and do not require additional surgery.
What are the risks associated with this type of treatment?
DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through your skin, and the lead or lead/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 your symptoms to return.
Medtronic DBS Therapy may cause worsening of some motor symptoms associated with your movement disorder, and may cause speech and language impairments. Stimulation parameters may be adjusted to minimize side effects and attain maximum symptom control. In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts and suicide have been reported.
Be sure to discuss the risks of this therapy with your physician.
Is the operation painful?
There may be some discomfort during the initial stages of the surgery. However, your brain is not sensitive to pain. Your doctor may numb your scalp to minimize discomfort during the first stage of the procedure, when the leads are positioned in the brain.
During the second stage, when the neurostimulator and lead extensions are implanted, you are placed under general anesthesia. You will then stay in the hospital for a short time, to recover from the surgery.
What does the stimulation feel like?
Most people don't feel the stimulation at all as it reduces their symptoms. However, some people may feel a brief tingling sensation when the stimulation is first turned on.
Higher levels of stimulation have been described as uncomfortable, jolting, or shocking. If the stimulation changes or becomes uncomfortable, contact your doctor immediately.
Does the brain stimulation system make any noise?
Will I be able to increase or decrease the strength of stimulation?
The strength of stimulation can be changed only by your doctor by using a wireless programmer.
Can other people see the components of the DBS System?
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.
Will I be able to resume my normal daily activities?
For the first few weeks after surgery, you should avoid strenuous activity, and arm movements over your shoulder, and excessive stretching of your neck. You may gradually want to try activities that were difficult before your surgery. Talk about this with your doctor first.
For children who have DBS Therapy, precautions should be taken before they resume active play and sports that could potentially result in damage to the components of the implanted system. If this occurs, your child's symptoms may return. Consult with your physician before allowing your child to participate in rigorous activities such as sports.
Can stimulation be used during pregnancy?
The safety of this therapy has not been established for patients who are pregnant.
What should I do if the stimulation changes or becomes uncomfortable?
Contact your doctor immediately.
What happens if the neurostimulator stops working?
Your symptoms will return. If you can't determine the possible cause and correct the problem, contact your doctor.
Is it safe to have medical tests with the system implanted?
Consult your doctor before engaging in any medical treatment (for example, ultrasound, mammogram, electrocautery or heart defibrillation). DBS Therapy should not be used for patients who will be exposed to diathermy (deep heat treatment). Magnetic Resonance Imaging (MRI) should not be considered unless absolutely needed. MRI should only be performed as described in the product labeling.
Will my insurance cover DBS Therapy?
Coverage for DBS Therapy is typically on a case-by-case basis for Medicare and private payers. Medtronic DBS Therapy for Dystonia may be eligible for Medicare coverage if the treatment is provided by a site that has Institutional Review Board (IRB) approval. Please contact your insurance company to see if your health plan provides coverage.
How long will the neurostimulator battery last?
Battery life will depend on the amount of stimulation you need for treating your symptoms.
What happens when my neurostimulator needs a new battery?
Before your battery runs out, you'll need to replace the neurostimulator through a surgical procedure. The DBS Therapy leads and extensions can typically stay in place and be reconnected to the new neurostimulator.
*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?