At Penn Medicine, a team comprising neurologists, neurosurgeons and radiologists are performing MR-guided focused ultrasound therapy (Exablate Neuro, Insightec, Dallas, TX) as an alternative to surgery in patients with essential tremor (ET) refractory to medication.
Full Answer
How is essential tremor treated using Focused Ultrasound?
Using ultrasound means:
- No incisions. This technology lets us perform brain surgery without any cutting. ...
- Precision and accuracy. This technology lets us create a small lesion in the exact right place. ...
- Immediate feedback. Throughout the procedure, we test for improvement of your tremor symptoms so we know exactly when the procedure is complete.
Does magnetic therapy help with essential tremor?
The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be used to help study brain function in healthy people and in those with neurological diseases like essential tremor. This portion of the study is being done to establish the optimal methods for stimulating the brain to measure its responses.
Is there a cure for essential tremor?
Treatment for essential tremor may not be necessary unless the tremors interfere with daily activities or cause embarrassment. Although there is no definitive cure for essential tremor, medicines may help relieve symptoms. How well medicines work depend on the individual patient. Two medications used to treat tremors include:
What are the treatments for essential tremor?
Essential tremor is a nervous system disorder ... neurosurgeon at the Hackensack University Medical Center Neuroscience Institute. The treatment was done with a system called exablate. Patients wear a helmet that has thousands of small speakers.
Is there an ultrasound treatment for essential tremor?
Focused ultrasound treats essential tremor by targeting and destroying a small patch of brain tissue responsible for essential tremor. The procedure does not involve cutting into your body, so recovery is quick and mostly without discomfort.
What is the cost of focused ultrasound?
The Centers for Medicare and Medicaid Services (CMS) has set the institutional payment for focused ultrasound treatment for essential tremor at approximately $10,000.
Is focused ultrasound Available on NHS?
Since April this year (2021) MRgFUS is available on the NHS in England for the treatment of people with essential tremor, having received a positive guidance from NICE in June 2018.
Is there any new treatment for essential tremor?
DBS: A Pacemaker for the Brain “DBS is a brain surgery that can help treat the debilitating symptoms of essential tremor when medication fails to provide consistent and adequate symptom control,” Dr. Beasley said.
Is focused ultrasound covered by insurance?
Is focused ultrasound covered by my insurance? The FDA has approved focused ultrasound to treat uterine fibroids, essential tremor and Parkinson's disease. Unfortunately, insurance companies don't currently cover this treatment for any of those conditions.
What are the side effects of focused ultrasound?
The most common side effects include:Nausea.Headache during the procedure.Temporary mild-to-moderate numbing and tingling in fingertips or lips.Temporary unsteadiness in walk, balance problems.Temporary speech or swallowing problems.
Is focused ultrasound performed in the UK?
Clinicians at Imperial College Healthcare NHS Trust have used high-intensity, focused ultrasound waves for the first time in the UK to treat patients with debilitating tremors, avoiding traditional, invasive brain surgery techniques.
Can I get HIFU on the NHS?
HIFU can be undertaken as a primary treatment with cura ve intent, although only available under the NHS in the context of a clinical trial. HIFU can also be used to treat recurrence after radiotherapy, which is available in some NHS hospitals..
What makes an essential tremor worse?
Certain medicines, caffeine or stress can make your tremors worse. Tremors may improve with ingestion of a small amount of alcohol (such as wine). Tremors get worse as you age. Tremors don't affect both sides of your body in the same way.
What will a neurologist do for hand tremors?
Deep brain stimulation (DBS) is the most commonly used surgery to treat essential tremor. During deep brain stimulation treatment, a neurostimulator (similar to a pacemaker) device is implanted in the chest and a lead is run from the device up to the area of the brain where the tremors are originating.
Is Focused Ultrasound permanent?
Focused ultrasound typically decreases symptoms immediately. It does not require adjustment, programming or additional procedures. But it is irreversible and permanent. Possible side effects may include headache, numbness and tingling, imbalance or gait changes, and others.
What is the best treatment for essential tremor?
Propranolol and primidone are the drugs used most often. Propranolol is the only drug approved for essential tremor by the US Food and Drug Administration. Evidence shows propranolol and primidone are effective treatments.
What is essential tremor?
Essential tremor (ET) is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the United States. ET is commonly viewed as a relatively benign disease.
When was Essential Tremor approved?
Essential Tremor. Focused ultrasound treatment for essential tremor has been approved by the Food and Drug Administration (FDA) in July 2016. Medicare approved the treatment in all US states as of July 12, 2020. Essential tremor (ET) is the most common movement disorder, affecting an estimated 3% of the population, ...
What is phase 3 of the randomized study?
Phase 3 Pivotal Clinical Study#N#Enrollment has been completed in a multi-center pivotal randomized study to evaluate the safety and efficacy of focused ultrasound for the treatment of medication-refractory essential tremor patients. Results of this study have been reviewed and approved by the FDA.
What is focused ultrasound therapy?
Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with essential tremor.
When will ultrasound be approved for Medicare?
In the US, the Medicare contractors in the various states incrementally approved focused ultrasound treatment for essential tremor. However, on July 12, 2020, all US sites have been approved for payment under Medicare. Commercial coverage and Medicaid will typically follow Medicare but should be evaluated with each company and region.
Where do ultrasound beams converge?
The primary target is a region in the thalamus called the ventral intermediate nucleus (Vim), but other adjacent targets and white matter pathways are also in use.
Is there a bilateral treatment for tremors in Canada?
There are two clinical trials in Canada for bilateral treatments of essential tremor. These studies are only open to Canadian Citizens.
How does ultrasound treat movement disorder?
Focused ultrasound treats essential tremor by targeting and destroying a small patch of brain tissue responsible for essential tremor. The procedure does not involve cutting into your body, so recovery is quick and mostly without discomfort.
What is UVA ultrasound?
UVA is the first program in the U.S. to treat essential tremor using focused ultrasound. Just one treatment is often all it takes to get lasting relief. View focused ultrasound transcript.
What is thalamotomy ultrasound?
Focused ultrasound thalamotomy is a special type of focused ultrasound procedure that can be very effective for managing essential tremor. Your care team will evaluate you as a potential candidate for this procedure. You are a good candidate if: You have a confirmed diagnosis.
Can you have a CT scan for tremors?
Your tremors are severe enough to consider a surgical procedure. Your condition limits your ability to perform daily activities. If you are a good candidate for focused ultrasound thalamotomy, you'll also need to undergo a special CT scan as part of your evaluation.
Can you get a focused ultrasound for essential tremor?
Not everyone with essential tremor is eligible for focused ultrasound. You may not be eligible for focused ultrasound if you have a pacemaker, kidney disease or can’t have an MRI. However, our team can help you find an alternative treatment, including deep brain stimulation.
How long does it take for essential tremors to improve?
Essential tremor trial. In one of the pivotal safety and effectiveness trials leading to FDA approval, patients reported a 50 percent improvement in their tremors and motor functions 3 months after treatment compared to baseline and maintained a 40 percent improvement 1 year after treatment.
What neurologic conditions can be treated with MR guided focused ultrasound?
Food and Drug Administration has approved focused ultrasound for the following conditions: Essential tremor. MR-guided focused ultrasound is approved for the treatment of essential tremor that cannot be controlled with medication.
What happens if you have a tremor after an MRI?
Once your tremor is improving the ultrasound energy is increased until a small lesion is formed. You will be awake during the entire procedure inside the MRI and will be able to speak to your medical team. You will be given an emergency stop button to hold during the procedure.
What conditions can MR guided ultrasound be used for?
Use of MR-guided focused ultrasound is being explored for other neurologic conditions including the tremors associated with multiple sclerosis, epileptic seizures that cannot be controlled by other treatment approaches, other movement disorders, stroke, brain tumors and neuropathic pain. Treating these other conditions is considered experimental at this time.
What is MR guided ultrasound?
Essential tremor. MR-guided focused ultrasound is approved for the treatment of essential tremor that cannot be controlled with medication. Approval is for treatment of one side of the brain only. Patients must be at least 22 years of age.
How long does it take for a tremor to go away?
Risks and complications include: Tremor could return months or years after the treatment. Tremor may not improve at all. Longer term (3 months or longer) or permanent (in about 10 to 15 percent of patients) muscle weakness, unsteadiness, sensory loss, or numbness or tingling in fingers or other areas of the body.
What is ultrasound energy?
Ultrasound (sound waves) is a form of energy that can pass through various types of tissues – skin, fat, bone, and muscle. Highly focused ultrasound is the method of treatment. Guided by the MR images, over 1,000 beams of ultrasound are concentrated and focused on a specific target in the body. The beams raise the temperature ...
When was ultrasound used for tremors?
Focused ultrasound has only been used to treat tremor in the United States since 2016, but the method was studied for decades before it was approved.
How does ultrasound technology help us create a lesion?
Precision and accuracy. This technology lets us create a small lesion in the exact right place. Thousands of ultrasound waves come together in one place smaller than a millimeter. This creates enough heat to cause a lesion .
Why is ultrasound important?
The most important reason is that ultrasound is incisionless. Focused ultrasound is brain surgery without an incision. No cutting means no risk of bruising, bleeding problems or infection.
What does ultrasound do to the brain?
We use ultrasound to ablate (burn) the part of your brain that causes tremor. Using ultrasound means:
Why can't I get an MRI?
Cannot have an MRI due to implanted metallic devices (like a cardiac pacemaker), body weight greater than 300 pounds, or allergies to MR contrast agent.
What is a test lesion?
We start with a test lesion. This is a temporary change to confirm that we are in the right place in your brain.
Does Medicare cover ultrasound for tremors?
Focused ultrasound for tremor is covered by Medicare. If you do not have Medicare, please contact your insurance carrier. Some private insurance carriers (like Aetna, Premera Blue Cross and Regence BCBS) do cover this treatment.
What is essential tremor?
Essential tremor (ET) is a common movement disorder, the most common one in the adult population. According to some studies its prevalence reaches up to 9% in people older than 60 years.1It usually presents as a bilateral postural 8–12 Hz tremor of the hands, followed by a kinetic and resting component too; the upper limbs are usually symmetrically involved but with disease progression the head and voice (less commonly legs, jaw, face, and trunk) may be involved too.2
What is a decision tree for tremors?
A Decision Tree for the Treatment of Tremor. In patients with a limb tremor, unilateral procedure (either DBS or ablation) may sometimes be sufficient to reduce the disability. In the case of disabling bilateral limb, head, voice, or trunk tremors, a bilateral procedure is necessary. As bilateral thalamotomies carry a high risk of dysarthria, dysphagia or balance problems, mostly Vim-DBS is applied. Other less studied targets are the Zi, especially in its caudal part (Raprl), Vop and Voa nuclei of the thalamus (modified from ref. 75). BoNT, Botulinum Neurotoxin; DBS, Deep Brain Stimulation; EMG, Electromyogram; GA, General Anesthesia; GKRS, Gamma Knife Radiosurgery; M/C, Midline and/or Contralateral Tremor; MCS, Motor Cortex Stimulation; MRgFUS, MRI-guided Focused Ultrasound (of Vim); QoL, Quality of Life; Raprl, Prelemniscal Radiation; RF, Radiofrequency; rTMS, Repetitive Transcranial Magnetic Stimulation; Vim, Ventrointermedius Nucleus of the Thalamus; Voa, Ventral Oral Anterior of the Thalamus; Vop, Ventral Oral Posterior Nucleus of the Thalamus. *To be considered in patients with a severe bleeding risk (e.g., ongoing anticoagulation). **Medication reduction can contribute to the worsening of midline/contralateral tremor.
What is the purpose of MRGFUS review?
The purpose of this review is to discuss the new developments and trials of MRgFUS in the treatment of ET and other tremor disorders.
What is ultrasound used for?
For years ultrasound has been used as an effective diagnostic tool in almost all fields of medicine and also as a therapeutic instrument in some areas. Examples of the latter are renal stones (lithotripsy) and cataract surgery (phacoemulsification).10The use of high-intensity focused ultrasound (HIFU) for ablation of living tissues goes back to the 1940s when Lynn11ablated fresh liver tissue without destruction of surrounding areas and then moved to the brain of living animals. The Fry brothers further explored HIFU to ablate brain tissues.12,13In 1959 their experience led to its first-time application in the treatment of tremor in patients with Parkinson’s disease (PD) in whom the globus pallidus was ablated after part of the skull bone was removed.14Later on, with the discovery of levodopa and afterward DBS, the role of ultrasound in treating movement disorders faded out. In the 1990s the combination of magnetic resonance imaging (MRI) with HIFU brought renewed interest in its use for the treatment of neurologic disorders.10
What is the lesional power of ultrasound?
The lesional power of ultrasound is based on two major mechanisms: thermal and non-thermal.10As for the former, the therapeutic goals of MRgFUS can be defined according to the level of ultrasound energy provided: low-intensity FUS (LIFU) can reversibly affect neural function, thus representing another way to perform neuromodulation; moderate energy levels can be employed to safely open the BBB for different aims (e.g., localized delivery of therapeutics); HIFU is sufficient to create a coagulation lesion in the brain with the goal of developing a minimally invasive way to create focal brain lesions. In fact, at a temperature of over 44°C for some seconds, irreversible cell death by coagulative necrosis will occur.22To reach these temperatures, usually an equal amount of ultrasound energy is applied continuously. As the energy absorption in the ultrasound beam path is lower, the surrounding tissue is spared.22Ultrasound’s non-thermal effects are due to alternating pressure and subsequently formation of air bubbles, a process termed acoustic cavitation. It has been hypothesized that adverse effects are due to non-thermal effects, so that the production of bubbles should be avoided during the procedure.23,24
What is MRGFUS surgery?
MRgFUS is a promising new surgical approach with a number of unknowns and unsolved issues. It represents a valuable option particularly for patients who refused or could not be candidates for other procedures, deep brain stimulation in particular.
What are the surgical techniques used in ET?
While there is no significant progress in the medical field of ET, the surgical field has been very active and there are advances in this area.7The surgical modalities used for ET include three major categories: 1) ablation (i.e., thalamotomy), 2) deep brain stimulation (DBS) of the ventrointermedius nucleus (Vim) of the thalamus, and 3) non-invasive (e.g., transcranial magnetic stimulation) and superficial brain stimulation (e.g., extradural or subdural motor cortex stimulation), which are still experimental and will not be discussed further.8There are different types of ablative therapies: a thalamotomy can be performed by using radiofrequency (RF), the gamma knife (GK), and the recently introduced magnetic resonance-guided focused ultrasound (MRgFUS).7,9These ablative (i.e., destructive) techniques can be further divided into invasive (RF) or non-invasive (GK and MRgFUS) techniques. Table 1highlights the principal features of the non-experimental surgical options available thus far.
What is the purpose of a focused ultrasound helmet?
This will attach to a focused ultrasound helmet that helps to hold the patient’s head still during the procedure. The helmet contains transducer elements that deliver ultrasound to a specific region of the brain.
What is FUS ultrasound?
FUS harnesses the power of ultrasound waves to reach deep brain regions without the need for scalpels or cutting.
How old do you have to be to be in a FUS trial?
Eligible research participants must be at least 18 years of age, a Canadian resident, have a confirmed diagnosis of essential tremor and have had at least one year pass since their first FUS procedure. This clinical trial will involve 12 patients.
What is the phone number for Sunnybrook ultrasound?
Phone: 416-480-6100 ext 3773 (please leave your contact information) For more information about this treatment or focused ultrasound at Sunnybrook Health Sciences Centre: sunnybrook.ca/focusedultrasound.
What happens after a MRI?
Following the procedure, patients are transferred to the neurosurgical ward for recovery and are discharged home a few hours later. Patients return to the hospital the next day for a follow-up MRI scan. The surgical and medical teams closely monitor each patient’s post-treatment recovery and longer term outcome.
How long does it take to recover from a MRI?
Patients will return for clinical imaging and assessment follow up one week after the procedure and again after three 3 months.
What is a FUS?
Focused ultrasound (FUS) is a non-invasive, image-guided surgical technology that uses multiple sources of ultrasound energy, arranged in a specially designed helmet, to target areas deep within the brain. The ability to focus ultrasound energy non-invasively, through the human skull was largely pioneered by scientists at Sunnybrook Health Sciences ...
How long does it take to get rid of a tremor?
The treatment takes approximately 4 hours and many patients can experience an immediate reduction in their tremor, however, their ability to regain skills such as writing, picking up a cup, using cutlery, ...
What is MRGFUS?
MRgFUS, or Magnetic Resonance-guided Focused UltraSound, is a safe, cost effective and incisionless procedure for the treatment of essential tremor .
What is essential tremor?
Essential tremor (ET) is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million people in the US. While ET is commonly viewed as a relatively benign disease, its associated disabling aspects – such as significant tremor of the hands – can impair a patient's ability to eat, shave, write, ...
What is MRI in medical?
During planning and treatment, the patient is fully conscious and lying on the treatment bed in an MRI scanner. MRI provides high-resolution visualization, patient-specific treatment planning, and continuous monitoring of the procedure.
Is FUS a non-invasive treatment?
FUS may offer the following benefits over other treatments: It is a non-invasive, single treatment so patients recover rapidly and return to activities of normal life quickly (usually the next day). It offers reduced risk of infection, damage to the non-targeted area, and blood clot formation.
Evaluation For Treatment
- If you're referred to our program for treatment, you'll have a CT scan to determine whether your skull's shape and thickness are suitable for focused ultrasound. (Some skull features prevent the focused ultrasound from reaching the target tissue with enough heat to be effective.) If our eval…
Who May Benefit
- The treatment is for people with a confirmed diagnosis of essential tremor that hasn't responded to medications. Patients must be over the age of 22.
Procedure
- The procedure is performed while you're in an MRI scanner. Before you get into the machine, we will shave your head to ensure hair doesn't obstruct the sound waves. You will wear a cap that allows cool water to circulate, protecting your scalp from the ultrasound's heat, and we'll secure your head in a frame that prevents it from moving during the procedure. You'll be awake and abl…
Recovery
- Some patients experience headaches, nausea or problems with balance during or right after treatment. These effects usually resolve quickly. Most patients are able to return to work and their normal activities within several days.
Risks
- Complications and side effects are uncommon but can include: 1. Temporary or permanent muscle weakness 2. Unsteadiness when walking 3. Sensory loss 4. Numbness or tingling in the fingers or elsewhere in the body
Medicare Approved The Treatment in All Us States as of July 12, 2020.
Focused Ultrasound Therapy
- Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with essential tremor. This novel technology focuses multiple beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue. How it Wor...
Clinical Trials
- A clinical trialin France is using focused ultrasound to treat ET. A multi-site US clinical trial investigating staged bilateral treatments for ET has been completed. A clinical trial in the UK and Spainis testing staged bilateral treatments. This group will treat the second side after at least nine months have passed after the first treatment. There are two clinical trials in Canadafor bilateral t…
Regulatory & Reimbursement
- The Exablate system manufactured by Insightec earned FDA approval to treat essential tremor in July 2016. It is also approved for treating essential tremor in Europe, Korea, Canada, Japan, Russia, Taiwan, and the Middle East. In the US, all treatment sites have been approved for payment under Medicare. Commercial coverage and Medicaid will typically follow Medicare but …
Additional Information
Notable Papers
- Suggested Reading: Focused Ultrasound for Essential Tremor Market Study(2021) Páez-Nova M, Spiegelmann R, Korn-Israeli S, Zibly Z, Illera-Rivera D, Daza-Cordoba C, Alcazar-Daza JC, Garcia-Ballestas E. Targeting the vim by direct visualization of the cerebello-thalamo-cortical pathway in 3 T proton density MRI: correlation with focused ultrasound lesioning. Neurosurg Rev. 2022 Feb …