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 Parkinsons disease. We recommend that they 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.
Am I A Candidate For Mrgfus
MRgFUS is FDA approved for the treatment of patients with essential tremor and tremor-dominant Parkinson disease. It can only be used to treat one side of the brain even if tremor is present on both sides. MRgFUS is not yet FDA approved to treat both sides. If first line medications fail to adequately control your tremor, your doctor may consider recommending either MRgFUS, deep brain stimulation, or radiosurgical thalamotomy. Compared to other surgical treatments for essential tremor, no device implant is needed, no incision is required, and the treatment works immediately. To read more about What to Expect During Consultation for Essential Tremor, .
Focused Ultrasound Shows Promise For Parkinsons Disease
Jeff Elias, MD, pioneered the use of focused ultrasound for the treatment of essential tremor and Parkinson’s disease.
A scalpel-free alternative to brain surgery has the potential to benefit people with Parkinsons disease symptoms that are much more severe on one side of the body, new research suggests.
More testing is needed, but the approach, which uses a technology called focused ultrasound, could offer a new option for patients whose symptoms are poorly controlled by medications and those who cannot or do not wish to undergo traditional brain surgery.
This small brain region, the subthalamic nucleus, had a very strong and potent effect on Parkinsonian symptoms when we targeted it with precise, focused ultrasound energy, said researcher Jeff Elias, MD, a neurosurgeon at UVA Health and a pioneer in the field of focused ultrasound. The key for the ultimate adoption of this new procedure will be further refinements of the technology to ensure reliability and safety.
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Conventional Treatments For Pd Tremors
PD differs from ET in many respects, and is generally accompanied by multiple symptoms that progressively worsen. In PD, the brain cells that produce a neurotransmitter called dopamine are gradually destroyed. In turn, this diminishes muscle control, leading not only to tremors that occur at rest and during voluntary movement, but also to restricted range of motion, postural impairment, loss of balance and coordination, and cognitive deficits in many cases.
Currently, conventional tremor treatments for PD patients include a range of medications . Some patients experience eventual side effects such as dyskinesia, and over time, medications generally become less effective. Surgical procedures have helped many PD patients greatly reduce tremor, but these do not affect other PD-related impairments. Even so, patients for whom hand tremors greatly reduced their ability to function experience improved quality of life when surgical procedures are successful.
Mrgfus As An Alternative To Surgery
MR-guided Focused Ultrasound is a new technology that uses sonic energy to ablate the tiny area of the brains thalamus that produces tremors. Advances in MRI allow accurate mapping of the thalamus to facilitate treatment planning, and also to guide the treatment itself. Improvements in ultrasound technology allow the sonic energy to be focused at the target from many directions when they converge upon the target, it produces the intense heat that accomplishes the ablation.
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Advantages Of Mrgfus For Parkinsons Disease Tremors
In 2016, Forbes Magazine carried an article on MR-guided Focused Ultrasound for essential tremor . Citing positive results from clinical trials, the article explained that The treatment doesnt require any implants, incisions or ionizing radiationi. As the news spread, Parkinsons disease patients who also suffer from tremors wondered if MRgFUS could eliminate their tremors, too.
Focused Ultrasound For Parkinsons Disease
Although elective procedures are currently being postponed in hospitals across the country because of the necessary focus on COVID-19, eventually our hospitals will return to normal and non-emergent procedures will be performed again. This will include elective procedures for the treatment of Parkinsons disease .
Two brain procedures that are approved for use in PD are deep brain stimulation and high intensity focused ultrasound . I encourage you to read more about DBS and view our webinar which outlines the newest features of this procedure.
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How Are Parkinsons Disease And Essential Tremor Treated
Medication is the first choice for Parkinsons treatment, but Parkinsons patients dont respond well to drugs or have side effects. In Essential tremor, the response rate to medications is less than Parkinsons disease and up to 30% may not tolerate medications or may have an unsatisfactory response. In these cases, surgical treatment may be considered.Before the arrival of FUS, surgical options for Parkinsons treatment included thalamotomy and deep brain stimulation .Both these options are considered minimally invasive although they involve incisions, use of drills to open a small hole in the skull and the insertion of one or more electrodes into the brain. In the case of DBS, the hardware is implanted into the brain and a pacemaker similar to a heart pacemaker is implanted into the chest wall.
Join The Parkinsons Forums: An Online Community For People With Parkinsons Disease And Their Caregivers
With the new technology, clinicians direct ultrasound waves to a brain structure called the globus pallidus, which helps regulate voluntary movement, to destroy damaged tissue, decreasing the uncontrolled movements that characterize Parkinsons disease.
Doctors use magnetic resonance imaging to create a temperature map of the brain, giving them a real-time picture of the region they want to hit with the sound waves. They then raise the energy, directly targeting that area of the brain to destroy the tissue.
Patients are awake and alert the entire time in the MRI scanner, enabling them to give clinicians constant feedback. They are fitted with a helmet through which the energy is converted into sound waves, which are then targeted to the globus pallidus. The approach is noninvasive, meaning there is no surgery or radiation treatment involved.
Current therapies to lessen movement and coordination problems in Parkinsons patients include levodopa , which is the most common. Patients with advanced Parkinsons may undergo surgery, known as deep brain stimulation, to implant micro-electrodes in the brain that help control tremors, rigidity and dyskinesia .
For people with Parkinsons disease and other movement disorders such as essential tremor, focused ultrasound is an appealing alternative to deep brain stimulation because it does not involve more invasive surgery, said Paul S. Fishman, MD, PhD, professor of neurology at UMSOM and a neurologist at UMMC.
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Ultrasound Treatment Might Ease Parkinson’s Tremors
WEDNESDAY, Nov. 27, 2019 — Ultrasound may provide lasting relief from the involuntary muscle movements that are so debilitating to people with Parkinson’s disease and another condition called “essential tremor,” a small study concludes.
The treatment is still scarce, but it appears to deliver significant and lasting tremor relief, Italian researchers report.
It’s called “focused ultrasound.” Though characterized as surgery, it’s actually a noninvasive procedure that involves no incisions.
For patients with uncontrolled muscle movements, clinicians use it to target beams of sound energy toward a small tremor-control center in the brain called the thalamus. The beams heat up the thalamus and destroy part of it.
“The clinical application of this technique for neurological diseases is an absolute novelty,” study author Dr. Federico Bruno, a radiologist at the University of L’Aquila in Italy, said in a statement. “Few patients know of this treatment option so far, and there are not many specialized centers equipped with the required technology.”
He pointed out that focused ultrasound received U.S. Food and Drug Administration approval less than three years ago as a tremor-control treatment.
Before then, patients had to rely on other interventions, according to Dr. Rachel Dolhun, vice president of medical communications for the Michael J. Fox Foundation in New York City.
But does it work?
Reaction To The Research
Sandeep Thakkar, DO, heads the Parkinsons and movement disorders program at the Pickup Family Neurosciences Institute in Newport Beach, California.
He says how long the ultrasound treatment is effective is debatable, but its effectiveness typically goes beyond what medications can accomplish.
We have very few medications that work and, even if they do, its short term, Thakkar told Healthline.
Jean-Philippe Langevin, MD, a neurosurgeon at Providence Saint Johns Health Center in Santa Monica, California, calls the study pretty significant.
This is mainly for patients with tremors in their upper extremities, who have trouble eating, getting dressed, things like that, medications for which dont work very well, Langevin told Healthline.
Theres a number of patients who dont want the . It could be theyre turned off by the thought of having an implant. The ultrasound treatment can be less invasive, he said.
Langevin adds that some of the risks associated with surgery are significantly reduced, although by destroying part of the thalamus, there can be risk of a person experiencing pins and needles sensations.
There can also be problems with speech. It can be garbled, he noted.
Ninety to 95 percent of people are not going to have side effects, Langevin said. Its not the entire thalamus . Its just a tiny portion.
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World First: Focused Ultrasound Opens Blood
In a groundbreaking, world-first clinical trial, a team of researchers from Sunnybrook Health Sciences Centre and University Health Network are using focused ultrasound technology to deliver a therapeutic directly to affected brain regions in patients with Parkinsons disease .
Parkinsons affects more than 6 million people around the world. It is a brain disorder that causes tremor, rigidity, slow movement and numerous other disabling symptoms. PD is a progressive neurodegenerative disease currently without a cure, which dramatically impacts a patients quality of life. Each patients symptoms can progress at a different rate.
Focused ultrasound harnesses the power of ultrasound waves to reach deep brain regions without the need for scalpels or cutting. In this study, researchers are using low intensity MRI-guided focused ultrasound to open the blood-brain barrier, which protects the brain from toxins but can also block potentially helpful medications.
The goal of this Phase I trial is to examine the safety of temporarily opening the blood-brain barrier in key motor regions known to be implicated in Parkinsons disease as well as delivering promising therapeutics directly to these areas of the brain, says Dr. Nir Lipsman, the studys co-principal investigator and Director of Sunnybrooks Harquail Centre for Neuromodulation.
What Is The Success Rate Of Fus Treatment
While there is still no cure for Parkinsons or Essential tremor, FUS represents an excellent method of controlling the tremor in these disorders. Out of the patients treated thus far at Sheba, 92% have shown improvement of tremor on a clinical disability scale. This includes such dramatic effects as being able to write effectively after treatment.
If you or a loved one is suffering from the significant tremor caused by Essential tremor or Parkinsons disease, contact Sheba right away to learn more about FUS treatment.
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How Do I Know If I Am Eligible For Treatment
Your doctor is the best person to ask about this. He or she will be able to tell you if you are a suitable candidate. In general, people who cannot go into an MRI will not be able to go through the treatment – this includes patients with metallic implants, patients who are claustrophobic and patients who are allergic to contrast agents – a dye used during MR imaging, patients who are over 300 lbs and patients who are under 22 years of age.
- If you have any kind of metallic implants, such as pacemakers, neurostimulators, spine or bone fixation devices, total joints, metal clips, screws, etc., you may not be a candidate. Any metallic implants must be non-magnetic to prevent injury to the patient from the MRs strong magnetic field.
- If you are not generally healthy enough to withstand the treatment and lie still in the same position for approximately 3 hours, you may not be a suitable candidate for this treatment.
- If you have had a recent myocardial infarction or have congestive heart failure , unstable angina pectoris , or spinal conditions, are you should discuss these issues with your doctor.
- If you have extensive scarring on the scalp, you may not be a good candidate.
- If you have any tumors inside the skull, you may not be a good candidate.
- If you are on dialysis, you may not be a good candidate.
- If you have an active infection or severe hematological, neurological or other uncontrolled disease, you may not be a good candidate.
Ultrasound Treatment Shows Promise For Managing Tremor
Positive results from a clinical trial of focused ultrasound therapy for tremor have been published in The New England Journal of Medicine.
“Studies using focused ultrasound for Parkinson’s are currently underway and if successful they could provide a non-invasive alternative treatment for people with Parkinson’s.”
Dr Beckie Port, Senior Research Communications Officer
Researchers at INSIGHTEC, a company with a focus on non-invasive surgical treatments, carried out a trial of their focused ultrasound treatment on 66 people with essential tremor and found significant improvements in hand tremor after 3 months.
Essential tremor is a type of uncontrollable shake or tremble in part of the body.
It is a separate condition to Parkinson’s but this form of treatment may prove to be helpful for people with Parkinson’s in the future.
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Is Focused Ultrasound Right For You
If your tremor is impacting your quality of life and medicine isnt helping, then focused ultrasound may be an option for you.
This treatment works best for patients who:
- Have tremor symptoms that are worse or advancing faster on one side than the other.
- Take anti-coagulants or have other conditions that make options like deep brain stimulation dangerous. You and your doctor will decide if you should stop blood thinners before focused ultrasound.
- Do not want to have invasive brain surgery or commit to the ongoing adjustments that deep brain stimulation requires.
This treatment does not work for patients who:
- Cannot have an MRI due to implanted metallic devices , body weight greater than 300 pounds, or allergies to MR contrast agent.
- Have a high skull density ratio. About 15 percent of people have skulls too dense for this treatment.
- Have a history of abnormal bleeding, or conditions like advanced kidney disease, unstable cardiac disease, severe high blood pressure, or certain brain problems.
- Are unable to tolerate being still for the three-hour treatment.
- Are pregnant.
Two Landmark Studies Advance Focused Ultrasound Treatment For Parkinson’s Disease
These two studies are a critical first step in using focused ultrasound to treat the underlying causes of Parkinson’s
José Obeso, MD, PhD, of of the Centro Integral de Neurociencias in Madrid and Nir Lipsman, MD, PhD, of Sunnybrook Health Sciences Centre in Toronto. Each doctor is leading a clinical trial using focused ultrasound to target the striatum in patients with Parkinson’s disease.
October 30, 2020 A team of researchers in Madrid, Spain, and another team in Toronto, Canada, are the first in the world to use focused ultrasound technology to target a new area of the brain in patients with Parkinson’s disease and potentially curb, or even reverse, its progression.
Both ongoing clinical trials focus on the striatum, a hub of neurons deep in the brain that is one of the principal components of the basal ganglia an area that plays a central role in facilitating voluntary movement. The severity of movement-related symptoms of Parkinson’s is associated with the neurodegeneration of dopaminergic nigrostriatal projection.
Focused ultrasound has previously gained international regulatory approvals for the treatment of tremor-dominant Parkinson’s, including US Food and Drug Administration approval in 2018. The trials in Madrid and Toronto represent the first application of the technology with the goal of stopping the progression of Parkinson’s, rather than merely treating the symptoms.
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Patient Story: Focused Ultrasound And Parkinsons Disease
It all started with a tiny tingle and I worried it was a sign of something bigger.
I was at a chili taste-testing contest when I reached to pick up a glass of hot apple cider and my baby finger tingled.
In that moment, I was concerned it was Parkinsons disease.
I had a feeling because my dad had had Parkinsons.
Over time I began noticing changes. My hand and arms started to tremor and my handwriting got progressively worse.
When my neurologist first gave me my diagnosis, I didnt want to believe it was Parkinsons. I wanted to fight it and beat it.
I still do.
Right now, there is no cure for Parkinsons disease. Its a progressive disease and its symptoms such as stiffness and tremor worsen over time. Each person with Parkinsons disease, experiences it differently.
For me, living with Parkinsons is a challenge. My main symptom is dyskinesia, which can include fidgeting or body swaying. My body isnt always doing exactly what I want it to do. Each day is different and depends on how my body is reacting to the medication that Im taking to help ease my symptoms.
I ended up retiring early from my job as a private school secretary. Day-to-day tasks take a bit longer to do, but I want to do things myself and I just take breaks when I need to.
The first participant of a world-first clinical trial
While some parts of my life are different, what hasnt changed for me is how determined I am to help in the search for a treatment or cure for Parkinsons disease.