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).
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.
- 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 >
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 pallidotomy)
This international pivotal trial has begun recruiting patients in the United States.
Parkinson’s dyskinesia (unilateral subthalamotomy)
This trial has completed recruiting patients in Spain.
Parkinson’s disease (Staged bilateral pallidothalamic tractotomy)
This trial is currently recruiting patients in Tokyo.
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)
Suggested Reading: Focused Ultrasound for Parkinson's Disease. March 2019.
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Click here for additional references on focused ultrasound for Parkinson's.
Animated treatment video courtesy of Insightec