Focused Ultrasound

Consult with your physician about treatment options for essential tremor and tremor-dominant Parkinson's disease. In order to be a candidate for the incisionless treatment, you must

• Be at least age 22
• Have a confirmed diagnosis of essential tremor that does not respond to medication
• Undergo a CT scan
• Be generally healthy enough to withstand the treatment and lie still in the same position for on average 2.5 hours
• Note that any metallic implants must be MRI-compatible to prevent injury to the patient

Review our frequently asked questions about focused ultrasound, safety information and cost. Download the PDF.  

What is Focused Ultrasound?

Focused ultrasound is an incisionless treatment for essential tremor patients who have not responded to medications. It is based on MR-guided Focused Ultrasound (MRgFUS) technology which uses sound waves to precisely treat deep in the brain guided by MR imaging.

How long has this procedure been approved by the FDA?

The FDA approved the Exablate Neuro device for treating essential tremor at the end of 2016.

Why is the treatment limited to age 22 and older?

The limitation is based on the FDA approval that is based on the clinical study that was performed and its criteria.

How do I prepare for treatment?

• The Focused ultrasound treatment requires that a patient have a cleanly shaven head. This is in order to ensure no interference of the sound waves.
• A local numbing medication will be applied and a standard frame will be secured to your head so that your head does not move during treatment.
• Your heart rate, blood pressure and blood oxygen levels will be monitored throughout the treatment. You will be awake, communicating with the treatment team throughout the treatment. You may be given additional medication to keep you comfortable.
• Cool water will circulate in the helmet around the top of your head and you will be kept warm in case you get chilled.

Why do I need to have my head shaved?

This is necessary for two reasons:

• Ultrasound waves do not travel well through air. In this treatment, water is used (like a gel used when having an abdominal ultrasound) as a conductive medium. The smooth-shaven scalp and a silicone cap enable a tight interface with the ultrasound transducer.
• Air bubbles could get trapped in the hair, blocking the ultrasound waves and absorbing energy which could potentially lead to skin burns.

What happens during treatment?

A series of MRI images will be taken for planning the treatment according to your specific anatomy. The treating physician will first apply light doses of ultrasound energy. This helps to identify the precise spot in the brain for treatment by assessing temporary tremor improvement and any potential side effects.

After each application of energy, called a sonication, you will be asked to perform specific tasks to evaluate your tremor improvement. Tasks may include touching your nose with your finger and/or drawing spirals.

The treating physician will then gradually increase the energy to create a small lesion, usually resulting in a therapeutic effect, improvement of hand tremor. Although individual results may vary, you should notice improvement during the treatment itself. The treatment lasts on average 2.5 hours.

If the thalamus is in the center of the brain, why doesn’t this treatment affect the rest of the brain?

The ultrasound waves pass through the rest of the brain. Only where they converge in the thalamus does the temperature rise, heating and creating a lesion that helps disrupt what is causing the tremor.

Why do I have to be awake?

Your feedback during the treatment is necessary as you will be asked to do different neurological tasks such as drawing spirals. This is so the physician can evaluate the improvement of your tremor and identify and address any potential side effects that you may be experiencing during the treatment.

When can I return to normal activities?

After treatment, the frame will be removed and you will go to the recovery room. The physician will let you know when you can go home and when you may need to return for a follow-up visit. Within days you should be able to return to normal activities. The treatment team will provide you with instructions related to your post-treatment recovery.

What results can I expect?

The outcomes of the Insightec sponsored clinical trial demonstrated an average 76.5% improvement in tremor severity at 3-year follow up in 54 subjects. Results may vary.

How safe is this treatment?

Overall, the focused ultrasound treatment has been shown to be safe for treating essential tremor with minimal risk, but as with any medical procedure, there are risks. You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience.

Insightec-sponsored clinical studies have shown that the most common adverse events after treatment are:

• Imbalance/gait disturbance (26% of study patients)
• Numbness/tingling (33%)
• Headache/head pain (51%)

Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.

For more information, visit Insightec.com/safety-information.

How long is the effect of the treatment expected to last?

The most recent data shows hand tremor improvement of the study subjects was mostly maintained at three years. There is the possibility that your tremor may return months or even years after the treatment, or that the tremor may not improve at all. And while the treatment may improve your tremor, it is important to understand that it does not treat the underlying disease nor prevent its progression.

Insurance Coverage

In which states is there Medicare coverage for the treatment for essential tremor?

Effective July 12, 2020, the MR-guided focused ultrasound treatment for medication-refractory essential tremor is a Medicare covered benefit in all 50 states.

Is Focused Ultrasound covered under Medicare Part A, Medicare Part B, or a supplemental Medicare plan?

The focused ultrasound treatment (also known as Magnetic Resonance guided Focused Ultrasound (MRgFUS) for treatment of essential tremor) is covered under Medicare Part B.

Do private health insurance plans cover the treatment?

Some private health insurance plans provide coverage for the treatment. For up-to-date information on insurance coverage, please visit online at usa.essential-tremor.com/insurance-coverage.

How much does the procedure cost?

To get a general idea of what you’ll have to pay, request a personalized estimate at  carilionclinic.org/pricing#price-estimates.