Outside Approval Square

Focused Ultrasound Therapy

Focused ultrasound is an early-stage, non-invasive, 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. Where the beams converge, the ultrasound produces a variety of therapeutic effects enabling Parkinson’s disease to be treated without surgery.

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).

Clinical Trials Square

For certain patients, focused ultrasound could provide a non-invasive 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.

Focused 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 or akinesia – 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. 

Advantages

  • 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 >

Tremor-dominant Parkinson's (thalamotomy)
This trial has completed enrollment for patients.

Parkinson's dyskinesia (unilateral pallidotomy)
This trial has completed enrollment for patients. 

Parkinson’s dyskinesia (unilateral subthalamotomy)
This international pivotal trial has begun recruiting patients in the United States.

Parkinson’s dyskinesia (unilateral subthalamotomy)
This trial is currently recruiting patients in Spain.

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. Patients should talk with their physician if they are not sure if they have tremor-dominated Parkinson’s disease. We recommend that they talk with the treatment site for questions about insurance coverage under 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

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

Notable Papers

Suggested Reading: Focused Ultrasound for Parkinson's Disease. March 2019.

Gallay M, Moser D, Federau C, Jeanmonod D. Radiological and Thermal Dose Correlations in Pallidothalamic Tractotomy With MRgFUS. Front Surg 2019 May 6:28 DOI=10.3389/fsurg.2019.00028

Cacciola A, Milardi D, Bertino S, Basile GA, Calamuneri A, Chillemi G, Rizzo G, Anastasi G, Quartarone A. Structural connectivity-based topography of the human globus pallidus: Implications for therapeutic targeting in movement disorders. Mov Disord. 2019 May 11. doi: 10.1002/mds.27712. [Epub ahead of print] PMID: 31077436

Gallay MN, Moser D, Federau C, Jeanmonod D. Anatomical and Technical Reappraisal of the Pallidothalamic Tractotomy With the Incisionless Transcranial MR-Guided Focused Ultrasound. A Technical Note. Front Surg. 2019 Jan 24;6:2. doi: 10.3389/fsurg.2019.00002. eCollection 2019.

Del Rey NL, Quiroga-Varela A, Garbayo E, Carballo-Carbajal I, Fernández-Santiago R, Monje MHG, Trigo-Damas I, Blanco-Prieto MJ, Blesa J. Advances in Parkinson's Disease: 200 Years Later. Front Neuroanat. 2018 Dec 14;12:113. doi: 10.3389/fnana.2018.00113. eCollection 2018.

Xhima K, Nabbouh F, Hynynen K, Aubert I, Tandon A. Non-invasive delivery of an α-synuclein gene silencing vector with MR-guided focused ultrasound. Movement Disorders 2018 Sept 33:1567-1579. doi: 10.1002/mds.101.

Luk KC. Focal ultrasound strikes a new tune for targeted drug delivery. Movement Disorders 2018 Sept 33:1513-1514. doi: 10.1002/mds.27494.

Ito H, Fukutake S, Yamamoto K, Tanaka S, Yamaguchi T, Taira T, Kamei T. Magnetic Resonance Imaging-guided Focused UltrasoundThalamotomy for Parkinson's Disease with Cardiac Pacemaker: A Case Report. Mov Disord Clin Pract. 2018 Mar 7;5(3):339-340. doi: 10.1002/mdc3.12578. eCollection 2018 May-Jun.

Fasano A, De Vloo P, Llinas M, Hlasny E, Kucharczyk W, Hamani C, Lozano AM. Magnetic resonance imaging-guided focused ultrasound thalamotomy in Parkinson tremor: Reoperation after benefit decay. Mov Disord. 2018 Mar 23. doi: 10.1002/mds.27348. 

Antonini A, Moro E, Godeiro C, Reichmann H. Medical and surgical management of advanced Parkinson's disease. Mov Disord. 2018 Mar 23. doi: 10.1002/mds.27340. 

Meng Y, Voisin MR, Suppiah S, Kalia SK, Kalia LV, Hamani C, Lipsman N. Is there a role for MR-guided focused ultrasound in Parkinson's disease? Mov Disord. 2018 Apr;33(4):575-579. doi: 10.1002/mds.27308. Epub 2018 Feb 24. 

Bretsztajn L, Gedroyc W. Brain-focussed ultrasound: what's the "FUS" all about? A review of current and emerging neurological applications. Br J Radiol. 2018 Mar 6:20170481. doi: 10.1259/bjr.20170481.

Martínez-Fernández R, Rodríguez-Rojas R, Del Álamo M, Hernández-Fernández F, Pineda-Pardo JA, Dileone M, Alonso-Frech F, Foffani G, Obeso I, Gasca-Salas C, de Luis-Pastor E, Vela L, Obeso JA. Focused ultrasound subthalamotomy in patients with asymmetric Parkinson’s disease: a pilot study. Lancet Neurol. 2018 Jan;17(1):54-63. doi: 10.1016/S1474-4422(17)30403-9.

Click here for additional references on focused ultrasound for Parkinson's.

Animated treatment video courtesy of Insightec

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