Essential Tremor

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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 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 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.

There is a clinical trial in Toronto for patients with essential tremor. 

There is a clinical trial in China for patients with a reduced SDR.

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. 

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 

Notable Papers

Suggested Reading: Focused Ultrasound: Transforming treatment of Neurodegenerative Diseases August 2022

Suggested Reading: Focused Ultrasound for Essential Tremor Market Study (2021)

Hino S, Maki F, Yamaguchi T, Kaburagi M, Nakano M, Iwamuro H, Takasaki M, Iijima K, Kanouchi M, Sasanuma J, Watanabe K, Hasegawa Y, Yamano Y. Effectiveness and safety of MR-guided focused ultrasound thalamotomy in patients with essential tremor and low skull density ratio: a study of 101 cases. J Neurosurg. 2024 Feb 2:1-9. doi: 10.3171/2023.11.JNS231799. PMID: 38306635 

Hashida M, Maesawa S, Kato S, Nakatsubo D, Tsugawa T, Torii J, Tanei T, Ishizaki T, Mutoh M, Ito Y, Tsuboi T, Mizuno S, Suzuki M, Wakabayashi T, Katsuno M, Saito R. Outcomes and Prognostic Factors of Magnetic Resonance-guided Focused Ultrasound Thalamotomy for Essential Tremor at 2-year Follow-up. Neurol Med Chir (Tokyo). 2024 Feb 15. doi: 10.2176/jns-nmc.2023-0202. PMID: 38355128 

Stoycheva T, Jameel A, Bain P, Nandi D, Jones B, Honeyfield L, Gedroyc W, Moore J. ‘Am I fixed, am I better now?’: undergoing MR-guided focused ultrasound for essential tremor: an interpretative phenomenological analysis. Front Neurol. 2024 Feb 8;15:1352581. doi: 10.3389/fneur.2024.1352581. eCollection 2024. PMID: 38390595 

Bagarinao E, Maesawa S, Kato S, Mutoh M, Ito Y, Ishizaki T, Tanei T, Tsuboi T, Suzuki M, Watanabe H, Hoshiyama M, Isoda H, Katsuno M, Sobue G, Saito R. Cerebellar and thalamic connector hubs facilitate the involvement of visual and cognitive networks in essential tremor. Parkinsonism Relat Disord. 2024 Feb 14;121:106034. doi: 10.1016/j.parkreldis.2024.106034. PMID: 38382401 

Gelman K, Melott J, Thakur V, Tarabishy AR, Brandt A, Konrad P, Ranjan M, Memon AA. MR-guided focused ultrasound thalamotomy for lithium-induced tremor: a case report and literature review. Front Neurol. 2024 Feb 1;14:1331241. doi: 10.3389/fneur.2023.1331241. eCollection 2023. PMID: 38362012 

Riis TS, Losser AJ, Kassavetis P, Moretti P, Kubanek J. Noninvasive modulation of essential tremor with focused ultrasonic waves. J Neural Eng. 2024 Feb 27;21(1). doi: 10.1088/1741-2552/ad27ef. PMID: 38335553 

Germann J, Santyr B, Boutet A, Sarica C, Chow CT, Elias GJB, Vetkas A, Yang A, Hodaie M, Fasano A, Kalia SK, Schwartz ML, Lozano AM. Comparative neural correlates of DBS and MRgFUS lesioning for tremor control in essential tremor. J Neurol Neurosurg Psychiatry. 2024 Jan 11;95(2):180-183. doi: 10.1136/jnnp-2022-330795. PMID: 37722831 

Zong R, Li X, Yin C, He J, Zhang D, Bian X, Huang L, Zhou J, Ling Z, Ma L, Lou X, Pan L, Yu X. Magnetic resonance-guided focused ultrasound for essential tremor: a prospective, single center, single-arm study. Neural Regen Res. 2024 Sep 1;19(9):2075-2080. doi: 10.4103/1673-5374.391192. Epub 2024 Jan 12. PMID: 38227538 

Odéen H, Shah LM, Rieke V, Parker DL, Rahimpour S. MR-Guided Focused Ultrasound Thalamotomy in the Setting of Aneurysm Clip. AJNR Am J Neuroradiol. 2024 Jan 25. doi: 10.3174/ajnr.A8109. PMID: 38272573 

Peters J, Maamary J, Kyle K, Olsen N, Jones L, Bolitho S, Barnett Y, Jonker B, Tisch S. Outcomes of Focused Ultrasound Thalamotomy in Tremor Syndromes. Mov Disord. 2024 Jan;39(1):173-182. doi: 10.1002/mds.29658. Epub 2023 Nov 14. PMID: 37964429 

Berger A, Chung J, Schnurman Z, Stepanov V, Pan L, Shepherd TM, Mogilner A. Comparison of Dentatorubrothalamic Tractography Methods Based on the Anatomy of the Rubral Wing. Oper Neurosurg (Hagerstown). 2024 Jan 30. doi: 10.1227/ons.0000000000001058. PMID: 38289086 

Golfrè Andreasi N, Braccia A, Levi V, Rinaldo S, Ghielmetti F, Cilia R, Romito LM, Bonvegna S, Elia AE, Devigili G, Telese R, Colucci F, Bruzzone MG, Messina G, Corradi M, Stanziano M, Caldiera V, Prioni S, Amami P, Fusar Poli M, Piacentini SHMJ, Grisoli M, Ciceri EFM, DiMeco F, Eleopra R. The Optimal Targeting for Focused Ultrasound Thalamotomy Differs between Dystonic and Essential Tremor: A 12-Month Prospective Pilot Study. Mov Disord Clin Pract. 2024 Jan;11(1):69-75. doi: 10.1002/mdc3.13911. Epub 2023 Nov 10. PMID: 38291839 

Free DB, Syndergaard I, Pigg AC, Muceli S, Hallett M, Farina D, Charles SK. Hand and distal tremor is most coherent with the activity of elbow flexors and wrist extensors in persons with Essential Tremor. J Appl Physiol (1985). 2023 Dec 21. doi: 10.1152/japplphysiol.00407.2023. PMID: 38126087 

Deveney CM, Surya JR, Haroon JM, Mahdavi KD, Hoffman KR, Enemuo KC, Jordan KG, Becerra SA, Kuhn T, Bystristky A, Jordan SE. Transcranial focused ultrasound for the treatment of tremor: A preliminary case series. Brain Stimul. 2023 Dec 19;17(1):35-38. doi: 10.1016/j.brs.2023.12.007. PMID: 38128826 

Gurgone S, De Salvo S, Bonanno L, Muscarà N, Acri G, Caridi F, Paladini G, Borzelli D, Brigandì A, La Torre D, Sorbera C, Anfuso C, Di Lorenzo G, Venuti V, D’Avella A, Marino S. Changes in cerebral cortex activity during a simple motor task after MRgFUS treatment in patients affected by essential tremor and Parkinson’s disease: a pilot study using functional NIRS. Phys Med Biol. 2023 Dec 15. doi: 10.1088/1361-6560/ad164e. PMID: 38100845 

Pérez-García C, López-Frías A, Arrazola J, Gil L, García-Ramos R, Fernández Revuelta A, Alonso-Frech F, López Valdés E, Trondin A, Yus-Fuertes M. Four-tract probabilistic tractography technique for target selection in essential tremor treatment with magnetic resonance-guided focused ultrasound. Eur Radiol. 2023 Nov 11. doi: 10.1007/s00330-023-10431-7. PMID: 37950079 

Hori H, Taira T, Abe K, Hori T. A novel high-precision fiber tractography for nuclear localization in transcranial magnetic resonance-guided focused ultrasound surgery: a pilot study. J Neurosurg. 2023 Nov 10:1-11. doi: 10.3171/2023.8.JNS231459. PMID: 37948701 

Peters J, Maamary J, Kyle K, Olsen N, Jones L, Bolitho S, Barnett Y, Jonker B, Tisch S. Outcomes of Focused Ultrasound Thalamotomy in Tremor Syndromes. Mov Disord. 2023 Nov 14. doi: 10.1002/mds.29658. PMID: 37964429 

Modi P, Qiu L, Fallah T, Courtwright A, Halpern CH. Magnetic Resonance Guided Focused Ultrasound Thalamotomy for Treatment of Severe Essential Tremor in a Lung Transplant Recipient-A Case Report. Transplant Proc. 2023 Oct;55(8):1988-1990. doi: 10.1016/j.transproceed.2023.06.012. Epub 2023 Jul 24. PMID: 37495484 

Yan X, Allen S, Lu M, Moore D, Meyer CH, Grissom WA. Dark band artifact in transcranial MR-guided focused ultrasound: Mechanism and mitigation with passive crossed wire antennas. Magn Reson Imaging. 2023 Nov;103:169-178. doi: 10.1016/j.mri.2023.07.018. Epub 2023 Aug 4. PMID: 37543175 

Lin J, Kang X, Lu H, Zhang D, Bian X, Zhou J, Hu J, Zhang D, Sepulcre J, Pan L, Lou X. Magnetic Resonance-Guided Focused Ultrasound Thalamotomy Rebalances Atypical Functional Hierarchy in Patients with Essential Tremor. Neurotherapeutics. 2023 Oct 16. doi: 10.1007/s13311-023-01442-9. PMID: 37843768 

Scantlebury N, Rohringer CR, Rabin JS, Yunusova Y, Huang Y, Jones RM, Meng Y, Hamani C, McKinlay S, Gopinath G, Sewell IJ, Marzouqah R, McSweeney M, Lam B, Hynynen K, Schwartz ML, Lipsman N, Abrahao A. Safety of Bilateral Staged Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for Essential Tremor. Mov Disord Clin Pract. 2023 Sep 15;10(10):1559-1561. doi: 10.1002/mdc3.13882. eCollection 2023 Oct. PMID: 37868927 

Blitz SE, Chua MMJ, Ng P, Segar DJ, Jha R, McDannold NJ, DeSalvo MN, Rolston JD, Cosgrove GR. Longitudinal MR imaging after unilateral MR-guided focused ultrasound thalamotomy: clinical and radiological correlation. Front Neurol. 2023 Oct 6;14:1272425. doi: 10.3389/fneur.2023.1272425. eCollection 2023. PMID: 37869137 

A Systematic Review Comparing Focused Ultrasound Surgery With Radiosurgery for Essential Tremor: Erratum. Neurosurgery. 2023 Oct 27. doi: 10.1227/neu.0000000000002736. PMID: 37888997 

Fleury V, Romascano D, Schneider D, Tuleasca C, Lorton O, Tomkova E, Catalano Chiuve S, Chytas V, Lüscher C, Burkhard PR, Salomir R, Levivier M, Momjian S. Successful MRI-Guided Focused Ultrasound Thalamotomy after Ipsilateral Gamma Knife Radiosurgery for Essential Tremor: A Case Report with Video. Stereotact Funct Neurosurg. 2023 Nov 2:1-7. doi: 10.1159/000534014. PMID: 37918368 

Büchele F, Mahendran S, Uhl M, Freudinger C, Maric A, Heeb NS, Oertel MF, Baumann CR, Stieglitz LH. Impact of target depth on safety and efficacy outcomes in MR-guided focused ultrasound thalamotomy for tremor patients. J Neurosurg. 2023 Nov 3:1-8. doi: 10.3171/2023.8.JNS23472. PMID: 37922562 

Click here for additional references from PubMed.

Pre- and post-treatment assessment videos courtesy of University of Virginia

FDA Approved
International Approval