FDA Approved square

FDA approved for both Tremor Dominant Parkinson’s Disease and Dyskinesia

Focused Ultrasound Therapy

Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with Parkinson’s disease. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces a variety of therapeutic effects enabling Parkinson’s disease to be treated without surgery. For movement disorders, the mechanism is ablation (thermal disruption of the tissue) that can be aimed at several different treatment targets. For the preclinical work in treating the underlying cause, the mechanisms can be temporarily disrupting the blood-brain barrier (BBB), which will allow desired therapeutics the ability to enter the brain. Opening the BBB also can enable undesired materials to more easily depart from the brain.

Outside Approval SquareAdvantages
Currently, there is no cure for Parkinson’s and the major options for treatment of motor symptoms include drug therapy and invasive surgery (e.g. deep brain stimulation, radiofrequency lesioning).

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost. In the long term, focused ultrasound has the potential to treat the underlying disease pathology and prevent progression and/or restore function.

Relief of Motor Symptoms

The FDA has approved the use of focused ultrasound for treatment of tremor-dominated Parkinson’s disease. See more in the regulation and approval section, below.

Clinical Trials SquareFocused ultrasound has the potential to achieve symptomatic relief by making thermal lesions deep in the brain to interrupt circuits involved with tremor and dyskinesia. Symptoms and targets being assessed for treatment using focused ultrasound include:

  • Parkinsonian tremor – target in the thalamus (thalamotomy)
  • Parkinsonian dyskinesia – target in the globus pallidus (pallidotomy) or subthalamic nucleus
  • Parkinsonian tremor, akinesia or dyskinesia – target in the pallidothalamic tract

At this time, focused ultrasound is only being assessed to treat one side of the brain, so it will affect tremor or dyskinesia unilaterally. Studies are being organized to assess the possibility of treating patients bilaterally, and one is included below. 


  • Focused ultrasound is non-invasive – no incisions, holes in the skull, electrodes in the brain – and therefore has reduced risk for infection and blood clots.
  • Precise targeting minimizes damage to non-targeted healthy brain.
  • Compared to deep brain stimulation, focused ultrasound is a single procedure, and does not require subsequent procedures/visits to replace batteries, repair broken wires, or adjust simulator settings. It also does not involve the collateral damage to healthy tissue or the risk of infections associated with implanting a foreign body.

Treating Underlying Pathology

Preclinical studies suggest focused ultrasound’s potential to restore function in Parkinson’s models. Focused ultrasound can temporarily open the blood-brain barrier (BBB) to improve the delivery of:

  • Genes, growth factors, stem cells, other neuroprotective and/or neurorestorative drugs
  • Anti-alpha synuclein antibodies

In October 2018, the Foundation had a multi-disciplinary workshop that aimed at using BBB opening in conjunction with potentially curative agents, to decide what research approaches have the most potential. Read the workshop summary >

Clinical Trials

There are several recent trials that assess the feasibility, safety, and preliminary efficacy of focused ultrasound to treat different symptoms of Parkinson’s. See a list of all Parkinson's clinical trials >

Parkinson’s dyskinesia (unilateral pallidotomy)
This international pivotal trial has completed enrollment of patients. 

Parkinson’s dyskinesia (unilateral subthalamotomy)
This trial has completed recruiting patients in Spain. See results and an editorial in the New England Journal of Medicine

Parkinson’s disease (Staged unilateral or bilateral pallidothalamic tractotomy [PTT])
This trial is currently recruiting patients at multiple locations. Please note that patients who have had focused ultrasound treatments for tremor (at the VIM nucleus) or dyskinesia (at the GPi) are not eligible to have the other side treated in this clinical trial. The staged bilateral treatment for this clinical trial is only for patients who had the PTT on the first side.

Parkinson’s disease (Staged bilateral pallidothalamic tractotomy)
This trial is currently recruiting patients in Tokyo.

See a list of treatment sites >
See here for a list of clinical trials sites >
See here for a list of laboratory research sites >

Regulatory Approval & Reimbursement

The Exablate system manufactured by Insightec is approved in Europe and in the US for treating tremor-dominant Parkinson's disease. In November 2021, it also earned approval in the US for treating additional movement disorders associated with Parkinson's disease, including mobility, rigidity and dyskinesia. We recommend that patients talk with the treatment site for questions about insurance coverage under Medicare, as some treatment sites are now being reimbursed by Medicare. Most commercial companies are not currently covering this procedure.

Preclinical Laboratory Studies

Preclinical studies suggest focused ultrasound’s potential to restore function in Parkinson’s models. Active studies are assessing focused ultrasound-induced BBB opening to improve the delivery of:

  • Genes, growth factors, stem cells, other neuroprotective and/or neurorestorative drugs (University of Virginia/Johns Hopkins University; University of Maryland; Columbia University; Chang Gung University in Taiwan; University of Toronto)
  • Anti-alpha synuclein antibodies (Columbia University; HM Puerta del Sur in Madrid/Institut Langevin in Paris)

Additional Resources

The Michael J. Fox Foundation for Parkinson’s Research
Exablate Neuro by Insightec LTD

Suggested Reading

Parkinson's Disease: Latest Treatments and Research. September 2020. 

Focused Ultrasound for Parkinson's Disease. April 2020. 
(See an archived version from March 2019.)

Notable Papers

Jackson LM, Kaufmann TJ, Lehman VT, Lee KH, Miller KJ, Hassan A, Klassen BT. Clinical Characteristics of Patients with Gait Instability after MR-Guided Focused Ultrasound Thalamotomy. Tremor Other Hyperkinet Mov (N Y). 2021 Oct 21;11:41. doi: 10.5334/tohm.643. eCollection 2021.

Sinai A, Nassar M, Sprecher E, Constantinescu M, Zaaroor M, Schlesinger I. Focused Ultrasound Thalamotomy in Tremor Dominant Parkinson's Disease: Long-Term Results. J Parkinsons Dis. 2021 Sep 25. doi: 10.3233/JPD-212810.

Parras O, Domínguez P, Tomás-Biosca A, Guridi J. The role of tractography in the localisation of the Vim nucleus of the thalamus and the dentatorubrothalamic tract for the treatment of tremor. Neurologia (Engl Ed). 2021 Sep 23:S2173-5808(21)00142-5. doi: 10.1016/j.nrleng.2019.09.008.

Lin J, Kang X, Xiong Y, Zhang D, Zong R, Yu X, Pan L, Lou X. Convergent structural network and gene signatures for MRgFUS thalamotomy in patients with Parkinson's disease. Neuroimage. 2021 Sep 1:118550. doi: 10.1016/j.neuroimage.2021.118550.

Xiong Y, Han D, He J, Zong R, Bian X, Duan C, Zhang D, Zhou X, Pan L, Lou X. Correlation of visual area with tremor improvement after MRgFUS thalamotomy in Parkinson's disease. J Neurosurg. 2021 Sep 3:1-8. doi: 10.3171/2021.3.JNS204329.

Yamamoto K, Ito H, Fukutake S, Odo T, Kamei T, Yamaguchi T, Taira T. Focused Ultrasound Thalamotomy for Tremor-dominant Parkinson's Disease: A Prospective 1-year Follow-up Study. Neurol Med Chir (Tokyo). 2021 May 8. doi: 10.2176/nmc.oa.2020-0370.

Jamora RDG, Chang WC, Taira T. Transcranial Magnetic Resonance-Guided Focused Ultrasound in X-Linked Dystonia-Parkinsonism. Life (Basel). 2021 Apr 26;11(5):392. doi: 10.3390/life11050392. P

Máñez-Miró JU, Rodríguez-Rojas R, Del Álamo M, Martínez-Fernández R, Obeso JA. Present and future of subthalamotomy in the management of Parkinson´s disease: a systematic review. Expert Rev Neurother. 2021 May;21(5):533-545. doi: 10.1080/14737175.2021.1911649. Epub 2021 May 6.

Gallay MN, Moser D, Magara AE, Haufler F, Jeanmonod D. Bilateral MR-Guided Focused Ultrasound Pallidothalamic Tractotomy for Parkinson's Disease With 1-Year Follow-Up. Front. Neurol., 09 February 2021

Gasca-Salas C, Fernández-Rodríguez B, Pineda-Pardo JA, Rodríguez-Rojas R, Obeso I, Hernández-Fernández F, Del Álamo M, Mata D, Guida P, Ordás-Bandera C, Montero-Roblas JI, Martínez-Fernández R, Foffani G, Rachmilevitch I, Obeso JA. Blood-brain barrier opening with focused ultrasound in Parkinson's disease dementia. Nat Commun. 2021 Feb 3;12(1):779. doi: 10.1038/s41467-021-21022-9.

Lin F, Wu D, Yu J, Weng H, Chen L, Meng F, Chen Y, Ye Q, Cai G. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: a systematic review and network meta-analysis. J Neurol Neurosurg Psychiatry. 2021 Jan 18:jnnp-2020-323656. doi: 10.1136/jnnp-2020-323656.

Martínez-Fernández R, Máñez-Miró JU, Rodríguez-Rojas R, Del Álamo M, Shah BB, Hernández-Fernández F, Pineda-Pardo JA, Monje MHG, Fernández-Rodríguez B, Sperling SA, Mata-Marín D, Guida P, Alonso-Frech F, Obeso I, Gasca-Salas C, Vela-Desojo L, Elias WJ, Obeso JA. Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson's Disease. N Engl J Med. 2020 Dec 24;383(26):2501-2513. doi: 10.1056/NEJMoa2016311.

Perlmutter J, Ushe M. Parkinson's Disease - What's the FUS? N Engl J Med. 2020 Dec 24;383(26):2582-2584. doi: 10.1056/NEJMe2031151.

Eisenberg HM, Krishna V, Elias WJ, Cosgrove GR, Gandhi D, Aldrich CE, Fishman PS. MR-guided focused ultrasound pallidotomy for Parkinson’s disease: safety and feasibility. JNS 27 Nov 2020.

Mahajan UV, Ravikumar VK, Kumar KK, Ku S, Ojukwu DI, Kilbane C, Ghanouni P, Rosenow JM, Stein SC, Halpern CH. Bilateral Deep Brain Stimulation is the Procedure to Beat for Advanced Parkinson Disease: A Meta-Analytic, Cost-Effective Threshold Analysis for Focused Ultrasound. Neurosurgery. 2020 Dec 9:nyaa485. doi: 10.1093/neuros/nyaa485.

Sharma VD, Patel M, Miocinovic S. Surgical Treatment of Parkinson's Disease: Devices and Lesion Approaches. Neurotherapeutics. 2020 Oct 28. doi: 10.1007/s13311-020-00939-x.

McDannold NJ, White PJ, Cosgrove GR. MRI-based thermal dosimetry based on single-slice imaging during focused ultrasound thalamotomy. Phys Med Biol. 2020 Sep 11. doi: 10.1088/1361-6560/abb7c4.

Behl T, Kaur I, Kumar A, Mehta V, Zengin G, Arora S. Gene Therapy in the Management of Parkinson's Disease: Potential of GDNF as a Promising Therapeutic Strategy. Curr Gene Ther. 2020 Aug 17. doi: 10.2174/1566523220999200817164051.

Meng Y, Pople CB, Kalia SK, Kalia LV, Davidson B, Bigioni L, Li DZ, Suppiah S, Mithani K, Scantlebury N, Schwartz ML, Hamani C, Lipsman N. Cost-effectiveness analysis of MR-guided focused ultrasound thalamotomy for tremor-dominant Parkinson's disease. J Neurosurg. 2020 Aug 7:1-6. doi: 10.3171/2020.5.JNS20692.

Martínez-Fernández R, Pineda-Pardo JA. Magnetic resonance-guided focused ultrasound for movement disorders: clinical and neuroimaging advances. Martínez-Fernández R, Pineda-Pardo JA. Curr Opin Neurol. 2020 Aug;33(4):488-497. doi: 10.1097/WCO.0000000000000840.

Miller TR, Guo S, Melhem ER, Eisenberg HM, Zhuo J, Kelm N, Dayan M, Gullapalli RP, Gandhi D. Predicting final lesion characteristics during MR-guided focused ultrasound pallidotomy for treatment of Parkinson's disease. J Neurosurg. 2020 Apr 24:1-8. doi: 10.3171/2020.2.JNS192590.

Wu CY, Huang RY, Liao EC, Lin YC, Ho YJ, Chang CW, Chan HL, Huang YZ, Hsieh TH, Fan CH, Yeh CK. A preliminary study of Parkinson's gene therapy via sono-magnetic sensing gene vector for conquering extra/intracellular barriers in mice. Brain Stimul. 2020 Feb 24;13(3):786-799. doi: 10.1016/j.brs.2020.02.024.

Lee J, Chang WS, Shin J, Seo Y, Kong C, Song BW, Na YC, Kim BS, Chang JW. Non-invasively enhanced intracranial transplantation of mesenchymal stem cells using focused ultrasound mediated by overexpression of cell-adhesion molecules. Stem Cell Res. 2020 Jan 30;43:101726. doi: 10.1016/j.scr.2020.101726.

Click here for additional references on PubMed.

Animated treatment video courtesy of Insightec

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