Focused ultrasound treatment for essential tremor has been approved by the Food and Drug Administration (FDA) in July 2016.
Medicare approved the treatment in all US states as of July 12, 2020.
The FDA approved staged bilateral treatment for essential tremor on December 20, 2022. Treatments are approved for the second side at least 9 months after the initial treatment.
Essential tremor (ET) is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the United States. ET is commonly viewed as a relatively benign disease.
However, the associated disabling aspects of ET, such as significant tremor of the hands, can impair patients’ ability to eat, shave, write, perform household activities, and function in the workplace.
The underlying etiology of ET is unclear, but cases often run in families (familial tremor). It has been estimated that approximately 50% of all cases are due to a genetic mutation, and the pattern of inheritance is most consistent with autosomal dominant transmission (i.e. dominant trait).
Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with essential tremor. This novel technology focuses multiple beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.
How it Works
Where the focused ultrasound beams converge, they produce precise ablation (thermal destruction of tissue), enabling ET to be treated noninvasively. The primary target is a region in the thalamus called the ventral intermediate nucleus (Vim), but other adjacent targets and white matter pathways are also in use.
- It is a noninvasive, single treatment that enables patients to recover rapidly and quickly return to activities of normal life (usually the next day).
- Compared to RF ablation or DBS, focused ultrasound offers a reduced risk of infection, of damage to the non-targeted area, and of blood clot formation.
- Focused ultrasound offers rapid resolution of symptoms.
- In contrast to lesioning performed with stereotactic radiosurgery, focused ultrasound does not use ionizing radiation, thus avoiding the side effects of exposure to radiation.
- Because it is non-invasive, focused ultrasound could be an option for medically refractory ET patients (those who do not respond well to medication) who do not want to undergo surgery.
A clinical trial in Los Angeles is using transcranial ultrasound neuromodulation to treat patients with essential tremor.
A clinical trial in France is using focused ultrasound to treat ET has been completed.
A multi-site US clinical trial investigating staged bilateral treatments for ET has been completed.
A clinical trial in the UK and Spain is testing staged bilateral treatments. This group will treat the second side after at least nine months have passed after the first treatment.
There are two clinical trials in Canada for bilateral treatments of essential tremor. These studies are only open to Canadian Citizens.
There is another clinical trial in Toronto for patients with essential tremor.
Please see a list of possible treatment sites here.
Regulatory & Reimbursement
The Exablate system manufactured by Insightec earned FDA approval to treat essential tremor in July 2016. It is also approved for treating essential tremor in Europe, Korea, Canada, Japan, Russia, Taiwan, and the Middle East.
In the US, all treatment sites have been approved for payment under Medicare.
Commercial coverage and Medicaid will typically follow Medicare but should be evaluated with each company and region. Some facilities have a cash payment option, for those who are not willing to wait for insurance decisions for payment. Prices vary, but a rough estimate is $40,000.
Device manufacturer, Insightec has established an informational website, including patient stories and access to treatment site information. They have also set up a Reimbursement Support Manager, who can help with questions about the status of reimbursements. Her contact information is: Kim Martin, Reimbursement Support Manager, 1-(866) 392-8478.
Suggested Reading: Focused Ultrasound: Transforming treatment of Neurodegenerative Diseases August 2022
Suggested Reading: Focused Ultrasound for Essential Tremor Market Study (2021)
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Click here for additional references from PubMed.
Pre- and post-treatment assessment videos courtesy of University of Virginia