Focused Ultrasound Therapy For Parkinson’s

Rapid Reversal Of Symptoms

Focused ultrasound is a completely incisionless procedure, performed without the need for anesthesia or an in-patient stay in the hospital. Patients, who are fully alert, lie in a magnetic resonance imaging scanner, wearing a specialized energy conversion helmet for the procedure. Ultrasonic energy is targeted through the skull to the globus pallidus, a structure deep in the brain that helps regulate voluntary movement. MRI images provide doctors with a real-time temperature map of the area under treatment.

Often before the procedure is even completed, patients experience relief from severe symptoms such as tremors, rigidity in the legs and arms, and side effects from medications that cause involuntary, erratic movements called “dyskinesia.”

About one million Americans have Parkinson’s disease, a neurodegenerative disorder that affects brain cells or neurons in a specific area of the brain that produce the brain chemical dopamine. Other current treatments for Parkinson’s include medications and deep brain stimulation from surgically implanted electrodes.

How Does The Focused Ultrasound Reduce Tremor

For essential tremor and Parkinsons disease, over 1,000 highly focused beams of ultrasound are concentrated on a specific area in the brains thalamus. The thalamus in the brain is a relay station of motor and sensory signals. Essential tremor and Parkinsons disease cause the thalamic circuitry to become abnormal, which results in tremors. The heat from the ultrasound causes a tiny burn or lesion on the targeted spot on the thalamus. Creating the tiny burn or lesion interrupts the abnormal activity, which relieves the tremors associated with these diseases.

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What Is Being Done At Sunnybrook

In this study researchers are investigating the feasibility of delivering of an enzyme called glucocerebrosidase to the putamen using low-intensity MRI-guided focused ultrasound. Glucocerebrosidase helps prevent alpha-synuclein, an abnormal protein, from accumulating in the brain. In PD, the glucocerebrosidase enzyme can be defective, resulting in alpha-synuclein build-up, lending to impaired cell health and neurodegeneration. Enzyme replacement therapy is a potential strategy to intervene in the underlying neurodegenerative process in PD.

As this clinical trial is in very early stages, the main scientific purpose is to confirm safety. Researchers are probing the safety and feasibility of using MRI-guided focused ultrasound to deliver enzyme replacement. Once safety is established, investigators will aim to determine if this is a promising method to reduce or slow neurodegeneration in PD.

Symptoms of PD are currently managed with various therapies, treated with medication or in some cases surgery. There are no available therapies to prevent neurodegeneration.

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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.

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.

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Am I A Candidate For Focused Ultrasound Treatment

You must have a confirmed diagnosis of essential tremor or tremor dominant Parkinsons disease to be referred for an MR-guided focused ultrasound. Your doctors will also want to be sure you have tried at least two medications and found that they do not help you and/or have undesirable side effects. The severity of your tremor and your overall health will be evaluated as part of the evaluation process.

Patients will need to undergo a CT scan to determine if they are candidates for treatment. You must be at least 22 years old. Since the procedure is done in an MRI scanner, there is a weight limit, generally in the range of 350 lbs.

You may not be able to have this treatment if you:

• Are pregnant
• If you have allergies to contrast dye used during MRI imaging.
• 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, so you won’t be injured by the MRI’s strong magnetic field.
• Not able or unwilling to tolerate the required prolonged stationary position during treatment .
• Health-related issues such as a recent myocardial infarction , congestive heart failure , unstable angina pectoris , or spinal conditions may be issues that you should discuss with your doctor.
• Have extensive scarring on the scalp
• Have skull tumors
• If you have an active infection or severe hematological, neurological, or other uncontrolled diseases.

What To Expect From Focused Ultrasound Treatment

Before your focused ultrasound treatment:

• Meet with Dr. Ahmed Raslan, neurosurgeon, to discuss the benefits and risks of focused ultrasound. We will also evaluate your condition to make sure focused ultrasound is the right treatment for you.
• You will need an MRI before treatment. If you already had an MRI with your neurologist, you may not need another one with us.

On treatment day:

• When you arrive for treatment, we will completely shave your head. This makes sure that nothing will block the ultrasound waves.
• You lay on a table that can slide in and out of an MRI machine during the procedure.
• We use numbing medicine at four different points on your scalp, then use pins to attach a frame. This frame will make sure your head is completely still during the procedure.
• We fit your head into a water-filled helmet that has more than 1000 ultrasound transmitters.
• We will find a baseline by asking you to draw a spiral or touch your nose.
• We can view your brain and control the ultrasound waves from a computer.
• We start with a test lesion. This is a temporary change to confirm that we are in the right place in your brain.
• This outpatient procedure takes up to three hours. You will be able to go home that day or the next day.
• You may experience brain swelling in the area for up to a week. This could cause temporary numbness, imbalance, or other neurological issues.
• Improvement to your tremor symptoms is immediate during the procedure.

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What Are The Risks And Possible Side Effects Of Focused Ultrasound Treatment

It is imperative that patients have realistic expectations and a clear understanding of the anticipated outcomes and potential risks before consenting to the procedure.

• After treatment, there is a small risk that you could develop temporary or permanent muscle weakness, unsteadiness when walking, sensory loss, or numbness or tingling in your fingers or elsewhere in your body.
• During the treatment, you may feel a headache or head pain. Nausea and vomiting have been reported during the application of the focused ultrasound energy.
• The most common potential short-term complications, defined as occurring on the day of treatment and up to 3 months following treatment, are transient numbness or tingling – typically mild to moderate in intensity and can last as briefly as the length of the sonication or up to several days.
• Very rarely, focused ultrasound could cause bleeding or skin infection.
• Potential long-term complications, defined as lasting longer than 3-months following treatment, include numbness or tingling, imbalance, unsteadiness, gait disturbance, and muscle weakness.
• The procedure is not recommended for those who have very thick skulls or cannot undergo a brain MRI.
• Additionally, if brain tissue is damaged, there may be muscle weakness, numbness, or sensory loss that may resolve after several months, or it may be non-reversible.

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.

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Low Intensity Focused Ultrasound To Help Deliver Therapies

While high intensity FUS is a treatment for PD as described above, low intensity FUS can be used in an entirely different way to help treat PD. This type of FUS may allow for disruption of the blood brain barrier. The blood brain barrier refers to the cells that line the blood vessels within the brain which keep foreign substances, such as toxins and microbes, in the bloodstream and out of the brain.

Normally, this mechanism is advantageous and protects the brain. However, the blood brain barrier may also keep out molecules that could help to treat brain diseases. Therefore, disrupting the blood brain barrier could allow for penetration of these molecules into particular areas of the brain. A whole variety of different molecules such as antibodies, nerve growth factors and gene therapy may be able to take advantage of this approach. Further research is necessary to determine if this will be a useful method for drug delivery into the brain.

Expanded Indication Includes Medication

byJudy George, Senior Staff Writer, MedPage Today November 5, 2021

The FDA expanded the approval of Exablate Neuro focused ultrasound to treat advanced Parkinson’s disease patients with mobility, rigidity, or dyskinesia symptoms, device maker Insightec announced Wednesday.

With this new indication, Exablate Neuro is approved for unilateral pallidotomy in medication-refractory Parkinson’s patients with moderate to severe motor complications.

The device uses MRI-guided focused ultrasound waves to target and ablate the globus pallidus, requiring no incisions or brain implants. “Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” said Paul Fishman, MD, PhD, of the University of Maryland, in a statement.

Exablate Neuro previously was approved to treat medication-refractory essential tremor and tremor-dominant Parkinson’s disease.

Early studies suggested that focused ultrasound subthalamotomy and pallidotomy performed on one side may reduce motor manifestations of Parkinson’s disease. A sham-controlled trial of patients with markedly asymmetric Parkinson’s disease found that focused ultrasound subthalamotomy performed in one hemisphere resulted in improved motor scores at 4 months, but was associated with adverse events including dyskinesias and other neurologic complications.

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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, .

How Do I Know That Mr

Your medical team will conduct a complete assessment of your condition, conduct any needed addition tests, and then discuss if you are a candidate for this or other treatment options .

Generally, MR-guided focused ultrasound may be an option if:

• You have a confirmed diagnosis of essential tremor or tremor-dominant Parkinsons disease
• Have tremors that have not been relieved by medications
• Have tremors that limit your ability to perform daily activities

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For Tremor Dominant Parkinson’s Disease

Parkinson’s disease is the second most common neurodegenerative condition, affecting about 1% of people over 60 years old. MR-guided focused ultrasound has become an attractive treatment option to improve tremor control for patients who do not respond to dopamine replacement medications.It is essential to recognize that focused ultrasound is not a cure for Parkinson’s disease, and it does not stop the progression of the disease. Some motor symptoms such as balance difficulties, speech problems, swallowing difficulties, and cognitive decline develop or worsen as Parkinson’s disease progresses and usually do not improve with focused ultrasound. Similarly, the non-motor complications of Parkinson’s disease, such as depression, problems with thinking or memory, constipation, or urinary changes do not improve after focused ultrasound.

How Does This Technique Compare To Dbs

DBS works in a different way to focused ultrasound, DBS overwhelms the faulty circuits whereas focused ultrasound destroys the circuits, to help with movement symptoms.

The advantage of DBS is once the electrodes are in the correct position in the brain you can turn it on and off, dial it up and down depending on the severity of the symptoms. Whereas, focused ultrasound is a permanent non-invasive procedure.

One of the current limitations of focused ultrasound is that it is currently only carried out to one side of the brain, since studies using treatment to both sides are only in their infancy at the moment. For most people with Parkinsons their movement symptoms impact both sides of their body. For this reason DBS still offers an excellent way to manage Parkinsons as it can control tremor on both sides.

We are starting to look at using focused ultrasound bilaterally, on both sides of the brain. But we need to be cautious, as in the past a technique called leisioning that targeted regions of the brain on both sides resulted in a high number of people developing speech problems. That being said, this previous technique was much less accurate than focused ultrasound and early results treating both sides are very promising.

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Are There Patients Who Are Not Candidates For Mr

This procedure may not be suitable if you:

• Have any type of metal implant, such as pacemakers, neurostimulator, spine or bone fixation devices, total joint replacements that are not MRI compatible.
• Have extensive scarring on your scalp.
• Have tumors inside the skull.
• Are on dialysis.
• Have an active infection or severe blood, brain, or other uncontrolled disease.
• Cannot tolerate lying still on a table for up to 4 hours.
• Are not able to stop antiplatelet or anticoagulation therapy.

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 Parkinsons are currently underway and if successful they could provide a non-invasive alternative treatment for people with Parkinsons.

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 Parkinsons but this form of treatment may prove to be helpful for people with Parkinsons in the future.

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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.

Is This A Cure For Parkinsons Disease

This current research trial is investigating the safety of injecting an enzyme in conjunction with opening the BBB in the putamen, one of the key regions of the brain implicated in Parkinsons. The putamen is a key structure in controlling the brains motor circuitry.

The hope is that this technique may be a way to open temporary access ports into the brain and allow large molecules such as enzyme therapies to enter.

This Phase 1 clinical trial is a very early, but necessary step in this process.

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