Vagus nerve stimulation involves the use of a device to stimulate the vagus nerve with electrical impulses. An implantable vagus nerve stimulator is currently FDA-approved to treat epilepsy and depression. There's one vagus nerve on each side of your body, running from your brainstem through your neck to your chest and abdomen.
In conventional vagus nerve stimulation, a device is surgically implanted under the skin on your chest, and a wire is threaded under your skin connecting the device to the left vagus nerve. When activated, the device sends electrical signals along the left vagus nerve to your brainstem, which then sends signals to certain areas in your brain. The right vagus nerve isn't used because it's more likely to carry fibers that supply nerves to the heart.
New, noninvasive vagus nerve stimulation devices, which don't require surgical implantation, have been approved in Europe to treat epilepsy, depression and pain. A noninvasive device that stimulates the vagus nerve was recently approved by the Food and Drug Administration for the treatment of cluster headaches in the United States.
Why it's done
About one-third of people with epilepsy don't fully respond to anti-seizure drugs. Vagus nerve stimulation may be an option to reduce the frequency of seizures in people who haven't achieved control with medications.
Vagus nerve stimulation may also be helpful for people who haven't responded to intensive depression treatments, such as antidepressant medications, psychological counseling (psychotherapy) and electroconvulsive therapy (ECT).
The Food and Drug Administration (FDA) has approved vagus nerve stimulation for people who:
- Are 4 years old and older
- Have focal (partial) epilepsy
- Have seizures that aren't well-controlled with medications
The FDA has also approved vagus nerve stimulation for the treatment of depression in adults who:
- Have chronic, hard-to-treat depression (treatment-resistant depression)
- Haven't improved after trying four or more medications or electroconvulsive therapy (ECT), or both
- Continue standard depression treatments along with vagus nerve stimulation
Additionally, researchers are studying vagus nerve stimulation as a potential treatment for a variety of conditions, including headaches, rheumatoid arthritis, inflammatory bowel disease, bipolar disorder, obesity and Alzheimer's disease.
For most people, vagus nerve stimulation is safe. But it does have some risks, both from the surgery to implant the device and from the brain stimulation.
Surgical complications with implanted vagus nerve stimulation are rare and are similar to the dangers of having other types of surgery. They include:
- Pain where the cut (incision) is made to implant the device
- Difficulty swallowing
- Vocal cord paralysis, which is usually temporary, but can be permanent
Side effects after surgery
Some of the side effects and health problems associated with implanted vagus nerve stimulation can include:
- Voice changes
- Throat pain
- Shortness of breath
- Difficulty swallowing
- Tingling or prickling of the skin
- Worsening of sleep apnea
For most people, side effects are tolerable. They may lessen over time, but some side effects may remain bothersome for as long as you use implanted vagus nerve stimulation.
Adjusting the electrical impulses can help minimize these effects. If side effects are intolerable, the device can be shut off temporarily or permanently.
How you prepare
It's important to carefully consider the pros and cons of implanted vagus nerve stimulation before deciding to have the procedure. Make sure you know what all of your other treatment choices are and that you and your doctor both feel that implanted vagus nerve stimulation is the best option for you. Ask your doctor exactly what you should expect during surgery and after the pulse generator is in place.
Food and medications
You may need to stop taking certain medications ahead of time, and your doctor may ask you not to eat the night before the procedure.
What you can expect
Before the procedure
Before surgery, your doctor will do a physical examination. You may need blood tests or other tests to make sure you don't have any health concerns that might be a problem. Your doctor may have you start taking antibiotics before surgery to prevent infection.
During the procedure
Surgery to implant the vagus nerve stimulation device can be done on an outpatient basis, though some surgeons recommend staying overnight.
The surgery usually takes an hour to an hour and a half. You may remain awake but have medication to numb the surgery area (local anesthesia), or you may be unconscious during the surgery (general anesthesia).
The surgery itself doesn't involve your brain. Two incisions are made, one on your chest or in the armpit (axillary) region, and the other on the left side of the neck.
The pulse generator is implanted in the upper left side of your chest. The device is meant to be a permanent implant, but it can be removed if necessary.
The pulse generator is about the size of a stopwatch and runs on battery power. A lead wire is connected to the pulse generator. The lead wire is guided under your skin from your chest up to your neck, where it's attached to the left vagus nerve through the second incision.
Vagus nerve stimulation
It’s called vagus nerve stimulation. Surgeons implant a device near the collarbone and run a wire to the vagus nerve. When the device fires it stimulates that nerve to send signals to the brain. This increases activity in areas that control mood.
After the procedure
The pulse generator is turned on during a visit to your doctor's office a few weeks after surgery. Then it can be programmed to deliver electrical impulses to the vagus nerve at various durations, frequencies and currents. Vagus nerve stimulation usually starts at a low level and is gradually increased, depending on your symptoms and side effects.
Stimulation is programmed to turn on and off in specific cycles — such as 30 seconds on, five minutes off. You may have some tingling sensations or slight pain in your neck and temporary hoarseness when the nerve stimulation is on.
The stimulator doesn't detect seizure activity or depression symptoms. When it's turned on, the stimulator turns on and off at the intervals selected by your doctor. You can use a hand-held magnet to initiate stimulation at a different time, for example, if you sense an impending seizure.
The magnet can also be used to temporarily turn off the vagus nerve stimulation, which may be necessary when you do certain activities such as public speaking, singing or exercising, or when you're eating if you have swallowing problems.
You'll need to visit your doctor periodically to make sure that the pulse generator is working correctly and that it hasn't shifted out of position. Check with your doctor before having any medical tests, such as magnetic resonance imaging (MRI), which might interfere with your device.
Implanted vagus nerve stimulation isn't a cure for epilepsy. Most people with epilepsy won't stop having seizures or taking epilepsy medication altogether after the procedure. But many will have fewer seizures, up to 20 to 50 percent fewer. Seizure intensity may lessen as well.
It can take months or even a year or longer of stimulation before you notice any significant reduction in seizures. Vagus nerve stimulation may also shorten the recovery time after a seizure. People who've had vagus nerve stimulation to treat epilepsy may also experience improvements in mood and quality of life.
Research is still mixed on the benefits of implanted vagus nerve stimulation for the treatment of depression. Some studies suggest the benefits of vagus nerve stimulation for depression accrue over time, and it may take at least several months of treatment before you notice any improvements in your depression symptoms. Implanted vagus nerve stimulation doesn't work for everybody, and it isn't intended to replace traditional treatments.
Additionally, some health insurance carriers may not pay for this procedure.
Studies of implanted vagus nerve stimulation as a treatment for conditions such as Alzheimer's disease, headaches and rheumatoid arthritis have been too small to draw any definitive conclusions about how well it may work for those problems. More research is needed.
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Dec. 07, 2018