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 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.
Advantages
- 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.
Clinical Trials
A clinical trial in Los Angeles, California is using low intensity focused ultrasound pulsation (LIFUP) to treat patients in an essential tremor pilot study.
A clinical trial in Los Angeles, California is doing a registry using low intensity focused ultrasound to treat patients with essential tremor in a pilot study.
A clinical trial in Los Angeles, California is using neuromodulation to evaluate the impact on patients with essential tremor.
A clinical trial in the University of Florida is evaluating the use of high intensity focused ultrasound on the mechanism of action for improvement in essential tremor.
A clinical trial in Texas is looking at the use of high frequency focused ultrasound on the patients who have essential tremor.
A clinical trial in Toronto, Ontario, Canada is using low intensity focused ultrasound to impact patients with multiple types of disorders, including many types of tremors, dystonia, epilepsy, and addictive substance abuse conditions.
A clinical trial in Calgary, Canada is using neuromodulation to treat patients with essential tremor.
There is a clinical trial in Toronto Western Hospital recording intracranial measurement for patients with treatment for movement disorders.
There is a clinical trial in Toronto, Canada, evaluating the clinical outcomes for patients treated for essential tremor.
There is a clinical trial in Toronto, Canada evaluating the impact on the virtual reality for patients being treated for essential tremor.
A clinical trial in Europe is using focused ultrasound to treat patients with bilateral tremor.
A clinical trial in San Paulo General Hospital is organizing and will treat patients for essential tremor soon.
A clinical trial is recruiting patient for 3-D tractography targeting for essential tremor.
A clinical trial is using transcranial ultrasound to treat essential tremor in the USA.
A clinical trial in Belgium is using focused ultrasound to see if the neuromodulation will results in improved targeting of the dentate nucleus.
A clinical trial in Taiwan is treating patients with refractory essential tremor, Parkinson’s disease tremor or dystonia using focused ultrasound.
A clinical trial in Bejing, China is organizing and will be treating patients for essential tremor soon.
There is another clinical trial in China treating patients with a reduced SDR.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
Treatment Sites
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.
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.
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.
Additional Information
- The Diann Shaddox Foundation for Essential Tremor Research
- The International Essential Tremor Foundation
- Hope Net
- APTES
- Tremor Action Network
Notable Papers
Suggested Reading: Focused Ultrasound: Transforming treatment of Neurodegenerative Diseases August 2022
Suggested Reading: Focused Ultrasound for Essential Tremor Market Study (2021)
Suggested Reading: Focused Ultrasound for Essential Tremor Market Study (2021)
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Silva NA, Hernandez A, Dwivedi AK, Mihas P, Roque DA, Krishna V. Exploring the Patient Pathway to Focused Ultrasound Ablation for Essential Tremor: A Mixed-Method Approach. Stereotact Funct Neurosurg. 2026 Jun 11:1-17. doi: 10.1159/000551996. PMID: 42275264
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Click here for additional references from PubMed.
Pre- and post-treatment assessment videos courtesy of University of Virginia