MRgFUS Focused Brain Ultrasound Now Available in Melbourne

ESSENTIAL TREMOR | PARKINSON’S DISEASE | UNCONTROLLABLE SHAKING

WHAT IS MRGFUS?

Neuravive is a relatively new MRI-guided noninvasive treatment, used primarily to treat essential tremor, tremor-dominant Parkinson’s disease, and certain types of chronic pain.

After a single treatment, most patients report an immediate relief or significant improvement in their symptoms.

Focused ultrasound can penetrate the skull without the need to make an incision or drill holes in the skull.

By having the patient conscious during the procedure and perform a non-permanent “test lesion” to assess the likely benefit and rule out side effects, the procedure can be performed relatively safely and reliably.

If you have additional questions, please email focus@precisionhealth.com.au.

Watch Nicholas’ remarkable story on YouTube

HOW DOES IT WORK?

Focused ultrasound (also known as MRgFUS and Neuravive) is an innovative neurosurgical platform which delivers ultrasound energy deep in the brain with incredible precision.

This deliberately creates a small scar or lesion in the brain without incisions.

This procedure is carried out without anaesthetic or incisions.

The neurosurgeon and neuroradiologist sit at a computer console in the MRI control room, using a computer and mouse instead of a surgical scalpel.

In the same way as using a magnifying glass to focus beams of light on a single point to burn a hole in a piece of paper, where each individual ultrasound beam passes through the tissue, there is no effect.

But, at the focal point, the multiple beams of focused ultrasound energy converge, and this results in many important biological effects.

Have a question? Email your referral or enquiry to focus@precisionhealth.com.au.

The main indications are essential tremor, Parkinson’s disease, and pain. MRgFUS is often an alternative to open brain surgery, including deep brain stimulation, and medications.

Advanced technology can produce ultrasound waves strong enough to penetrate the skull.

State of the art software and computerised surgical navigation platforms modify the delivery, according to individual skull shape and thickness.

Up to 1024 ultrasound waves precisely heat and ablate a deep brain target without the need for surgical incisions or manual manipulation of the brain.

Because the anatomical targets are small and are often positioned amidst critical brain structures, treatment is guided by MR imaging.

High resolution MRI provides detailed imaging, real-time thermal feedback and continuous treatment monitoring.

By focussing these ultrasound beams on a specific region of the brain, neural pathways that cause tremor or other neurological problems can be disrupted, frequently alleviating or dramatically reducing those symptoms.

If you have additional questions, please email focus@precisionhealth.com.au.

HOW CAN TREMOR BE TREATED?

In very mild case of tremor, no treatment may be required. Medications are typically used in the first instance for more problematic tremor, and neurosurgical procedures may be considered in more severe cases where non-surgical treatment has failed.

1. Medications
   Pharmacological options include beta-blockers, certain anti-seizure medications and also some anti-anxiety drugs.Around half of all patients will derive some reduction in tremor though the side effects, including fatigue or drowsiness, can be limiting.
2. Thalamotomy (traditional open procedure)
   In this procedure, a small hole is drilled in the skull and a radiofrequency probe is inserted through the brain and into the thalamus. These cells are then destroyed with heat, sometimes leading to alleviation of the tremor. This procedure carries risks including bleeding, stroke, infection, seizures and death.
3. Deep brain stimulation
   Deep brain stimulation involves drilling a hole in the skull and inserting an electrode into the thalamus or posterior subthalamic area. The electrode is then connected via a wires to a battery (implantable pulse generator) located in the chest region.It carries similar risks to thalamotomy, with the additional risk of hardware infection.The implantable pulse generator requires programming adjustments from time to time, and also requires replacement (every 10-15 years for rechargeable devices). Rechargeable devices often need recharging one or more times per week.
4. MRI-Guided Focussed Ultrasound (MRgFUS)
   This is the modern day thalamotomy, with some key advantages over traditional thalamotomy and deep brain stimulation. It does not require incisions, holes are not drilled in the skull, and probes are not inserted into the brain.

WHAT ARE THE BENEFITS OF FOCUSED ULTRASOUND?

• It is non-invasive, with generally lower major risks than open surgery and a shorter recovery time
• It is carried out as a single treatment. Patients typically recover rapidly and quickly return to their usual daily activities (frequently within the next day or two)
• Focused ultrasound frequently offers rapid improvement of symptoms.Other technologies such as Gamma Knife radiosurgery have a significant delay before clinical improvement is seen, and deep brain stimulation requires regular programming of the electrical device, and either frequent recharging or further surgery to replace the battery when it expires
• In contrast to stereotactic radiosurgery lesioning, focused ultrasound does not use radiation, thereby avoiding the side effects of radiotherapy.
• No anaesthetic is required, therefore patient with significant medical comorbidity are eligible for this treatment

HOW CAN I BE ASSESSED FOR SUITABILITY FOR THIS TREATMENT?

Patients with various types of tremor, as well as Parkinson’s Disease and dystonia, may be assessed for suitability for Neuravive.

Typically the assessment includes:

• Diagnostic confirmation of the type of movement disorder
• Measurement of skull density on CT, and brain morphology on MRI
• Assessment with the standard rating scales
• Consideration of quality of life issues
• Assessment of other health problems which may be relevant

The assessment team includes a neurologist, neurosurgeon, neuroradiologist, and sometimes a rehabilitation physician and neuropsychologist.

Have a question? Email your referral or enquiry to focus@precisionhealth.com.au.

ARE SOME PATIENTS NOT CANDIDATES FOR MR-GUIDED FOCUSED ULTRASOUND?

This procedure may not be suitable for patients:

• With non-MRI compatible implants, including some pacemakers, neurostimulators, spine or orthopaedic implants
• With extensive scarring on the scalp
• With tumours in the brain
• Who are on dialysis
• Who have an active infection
• Who cannot lay still on a table for up to 4 hours
• Who are unable to stop antiplatelet or anticoagulation therapy
• Have significant claustrophobia

HOW DO I REQUEST AN INITIAL CONSULTATION?

If you are suffering from Essential Tremor, Parkinson’s disease or another type of tremor or movement disorder and would like to know whether you might be suitable for treatment with focused ultrasound, please request a consultation and our clinical care coordinator will contact you:

Alternatively, please email your referral or enquiry to focus@precisionhealth.com.au

Our assessment process includes:

• Confirmation of your diagnosis and its impact on your quality of life.
• Other relevant medical condition and medications you are on.
• Brain scanning with MRI and CT

Our clinical assessment team includes a movement disorder neurologist and neurosurgeon.

Our clinical care coordinator will coordinate all aspects of your assessment from the time we receive your referral. If you have any questions, please contact us.

WHAT IS THE TREATMENT PROCESS?

1. Patient Preparation
   Several days or weeks before treatment, a CT scan is done to assess the shape, thickness and density of the patient’s skull. If the skull is too thick or dense the patient may be unsuitable for this treatment. A urinary catheter may be placed to drain the bladder. Vital signs (heart rate, blood pressure, oxygen level) will be monitored. The patient is positioned on the treatment bed in the MRI room with their head places in the Exablate Neuro helmet. Cool water is circulated around the scalp to avoid heating.
2. Planning, Testing and Target Verification
   MRI images are taken to plan the treatment and identify the target.
   Prior to treatment, low energy ultrasound energy is applied to accurately pinpoint the target on the real-time MRI. Then, several moderate level ultrasound pulses allow assessment of therapeutic response and any potential side effects.
3. Treatment
   The actual focused ultrasound treatment comprises up to 1024 ultrasound waves precisely converging at the target in the thalamus. At that focal point, temperatures increase to around 60°C, causing thermal ablation of the tissue. Active monitoring is undertaken during the procedure to ensure accuracy and safety. This is achieved with MRI-guided feedback of temperature changes at the target.Treatment is generally unilateral, typically treating the dominant and/or most severely affected hand.
4. Assessment
   The patient is clinically assessed during and immediately after the procedure. The outcome is confirmed using an MRI scan immediately post-procedure. Treatment typically takes between 3-4 hours. Many patients experience an immediate reduction in their tremor and frequently return to normal daily activities the following day.

If you have additional questions, please email focus@precisionhealth.com.au.

WHAT ARE THE OUTCOMES?

Most patients experience a significant improvement to their tremor through the treatment process.

Published outcomes include the following improvements in tremor when compared to baseline (pre-treatment):

• 1 yr after treatment- 69%
• 2 yrs- 75%
• 3 yrs- 76.5%

In tremor-dominant Parkinson’s disease, the study that led to FDA approval reported a 62 percent median improvement in hand tremor 3 months after treatment compared with baseline.

Have a question? Email your referral or enquiry to focus@precisionhealth.com.au.

WHAT ABOUT SIDE EFFECTS?

Like any type of surgical procedure, potential side effects and complications occur from time to time.

Side-effects reported include numbness in the face or hand, and gait disturbance.

In most cases these are mild and temporary, but they can be ongoing in some patients.

The long-term safety profile indicates that 74% of adverse events were mild, and the rest were moderate.

Of the total adverse events, almost 50% resolved within 30 days of the procedure.

Specifically, the most common side effects are:

• musculoskeletal weakness 2%
• gait disturbance 2%
• unsteadiness or imbalance 4%
• numbness 9%

HOW LONG DOES THE TREMOR REDUCTION LAST?

Current studies on Essential Tremor provide up to 3-4 years of outcome data, with the vast majority of patients obtaining a good and sustained benefit.

WHAT IS THE PROCESS TO BE ASSESSED?

1. Register your interest You can contact our office by phone (03 8862 0000), email (focus@precisionhealth.com.au) or via our appointment request form to register your interest and begin the assessment process.
2. Phone or Email Communication A member of our team will call you to obtain some relevant information, screen you for suitability, and arrange the medical and radiological assessments (if appropriate).
3. Medical Assessment The key medical assessments are:
   1. Consultation with a movement disorder neurologist
   2. CT & MRI Scan
   3. Consultation with neurosurgeon, Prof Richard Bittar

   The information obtained during your consultations and scans are collated and assessed by our multidisciplinary team, and a treatment recommendation is made.

4. Scheduling the Procedure

If you have additional questions, please email focus@precisionhealth.com.au.

COMMON QUESTIONS

WHAT ARE THE COSTS INVOLVED WITH THE ASSESSMENT FOR THIS TREATMENT?

Consultations with the neurologist and neurosurgeon take place in their consulting suites and are billed at their standard specialist rates.

This information, together with the likely Medicare rebates, will be provided to you before your booking is confirmed.

In order to be certain that you receive a Medicare rebate, please ensure that you obtain a referral from your GP or neurologist.

The cost of the actual treatment is around $30,000.

DO YOU ACCEPT REFERRALS FROM INTERSTATE OR OVERSEAS?

Yes, we do accept referrals from interstate and overseas.

The above process can be tailored to the individual patient’s situation and travel itinerary.

Have a question? Email your referral or enquiry to focus@precisionhealth.com.au.

IS THE MRGFUS PROCEDURE COVERED BY MEDICARE OR PRIVATE HEALTH FUNDS?

No. Medicare currently does not provide reimbursement for the MRgFUS procedure, nor do the private health funds. Unfortunately, this means that there is a significant out of pocket expense to have Focused Ultrasound.

DO I HAVE TO STAY IN HOSPITAL OVERNIGHT?

Yes, you will need to stay in hospital for observation overnight following your procedure.

AM I ABLE TO DRIVE OR TRAVEL BY AIR FOLLOWING THE PROCEDURE?

You should avoid driving for 2 weeks after the procedure. You can travel home by air a few days after the procedure.

WHEN CAN I RETURN TO NORMAL ACTIVITIES AFTER THE PROCEDURE?

We recommend light physical activity for 2-3 weeks after the procedure, at which time normal activities can be resumed.

WHAT FOLLOW-UP IS RECOMMENDED?

You will undergo several clinical reviews during the first 12 months after your procedure, and then every year thereafter. We will arrange an MRI brain at 3 months postoperatively.

HOW LONG DOES THE PROCEDURE TAKE?

The entire procedure, from preparation to getting off the table, takes about 3-4 hours.

WHAT HAPPENS IMMEDIATELY AFTER THE FOCUSED ULTRASOUND TREATMENT?

You will move to a recovery room for observation. You will remain in hospital for 24 to 48 hours.

WHAT ARE THE BENEFITS AND ADVANTAGES OF MR-GUIDED FOCUSED ULTRASOUND?

Using this procedure:

• No incisions are needed
• No holes drilled in the skull
• No hardware or devices are implanted
• No radiation exposure
• No general anaesthesia required
• Minimal risk of infection or bleeding when compared with incision-based procedures
• Specialists can assess if treatment is working during the actual procedure, and can stop if adverse effects occur

WHAT ARE THE SIDE EFFECTS OF MR-GUIDED FOCUSED ULTRASOUND?

The most common side effects include:

• Nausea
• Headache during the procedure
• Temporary numbness and tingling in the lips or fingertips
• Temporary unsteadiness and balance problems
• Temporary speech or swallowing problems

These side effects sometimes start several days or weeks after treatment.

If you have additional questions, please email focus@precisionhealth.com.au.

WHAT ARE THE LONGER-TERM RISKS AND COMPLICATIONS OF MR-GUIDED FOCUSED ULTRASOUND?

The longer term risks and complications include:

• Tremor could return months or years later
• Tremor might not improve at all
• Muscle weakness, unsteadiness, sensory loss, or numbness or tingling in fingers or other areas of the body

HOW DO I KNOW THAT MR-GUIDED FOCUSED ULTRASOUND IS THE BEST OPTION TO TREAT MY TREMOR?

Our medical team will conduct a complete assessment of your condition, and will then discuss whether you are a candidate for this or other treatment options (such as deep brain stimulation).

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

• A confirmed diagnosis of tremor-dominant Parkinson’s disease or essential tremor
• Tremor that is inadequately relieved by medications
• Tremor that limits your ability to perform daily activities