What side effects are associated with this type of intervention?

The most common treatments for Essential Tremor include medications like propranolol and primidone, as well as surgical interventions such as Deep Brain Stimulation (DBS) and thalamotomy. For treatments similar to MRgFUS Thalamotomy, such as DBS and traditional thalamotomy, known side effects include speech impairment, balance issues, and dysarthria. MRgFUS Thalamotomy itself is associated with fewer side effects compared to traditional methods, but patients may still experience temporary numbness, imbalance, and mild cognitive changes. Long-term data on MRgFUS are still being collected to fully understand its safety profile.

What prior FDA approvals exist?

The FDA has approved several treatments for Essential Tremor, including medications like propranolol and primidone, which are commonly used as first-line therapies. For patients who do not respond to medication, surgical options such as Deep Brain Stimulation (DBS) targeting the thalamus have been approved. More recently, the FDA has approved Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for the treatment of medication-refractory Essential Tremor. MRgFUS is a non-invasive procedure that uses focused ultrasound waves to create a lesion in the thalamus, thereby alleviating tremors.

What other types of research exist?

Promising novel alternatives to MRgFUS Thalamotomy for Essential Tremor patients include: 1) Deep Brain Stimulation (DBS), which involves implanting electrodes in the brain to modulate neural activity; 2) Transcranial Magnetic Stimulation (TMS), a non-invasive method using magnetic fields to stimulate nerve cells in the brain; and 3) Focused Ultrasound (FUS) without MRI guidance, which is being explored for its potential to target tremor-related brain regions with precision. These alternatives are being actively researched and have shown potential in clinical trials.

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Procedure

Focused Ultrasound Thalamotomy for Essential Tremor (BEST-FUS Trial)

N/A

Waitlist Available

Led By Andres Lozano, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist

The patient previously underwent a MRgFUS (> 6 months ago)

Must not have

Clinically relevant speech impairment (e.g. impairment of intelligibility)

Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post operative month 1, 3, 12, 24, 36

Awards & highlights

Summary

This trial is testing a non-invasive brain treatment using focused ultrasound on patients with essential tremor who have already had successful treatment on one side of their brain. The treatment works by using sound waves to heat and remove parts of the brain causing tremors.

Who is the study for?

This trial is for adults over 18 who have essential tremor and previously had successful MRgFUS thalamotomy on one side. They must want treatment for the other side, with a neurologist-confirmed diagnosis of ET or ET plus, and their quality of life should be affected by the tremor.

What is being tested?

The study tests if focused ultrasound thalamotomy can safely treat essential tremor in the untreated brain hemisphere. Initially, 10 patients will undergo this procedure; if safe, an additional 40 will join. The main goal is to see how much it improves their tremors after a year.

What are the potential side effects?

Potential side effects include issues related to the nervous system like speech problems or balance difficulties. These will be monitored closely at several points post-treatment up to three years.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Essential Tremor by a specialist.

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I had MRgFUS treatment over 6 months ago.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have trouble being understood when I speak.

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I have trouble walking or balancing, and may use a wheelchair, walker, or cane.

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My doctor has advised against me joining this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post operative month 1, 3, 12, 24, 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post operative month 1, 3, 12, 24, 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and post operative month 1, 3, 12, 24, 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in QUEST Score

Patient-based Assessment of Utility

Secondary study objectives

Dysgeusia

Falls

Gait Assessment (NRS-11)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Essential Tremor (ET) include MRgFUS Thalamotomy, Deep Brain Stimulation (DBS), and medications. MRgFUS Thalamotomy uses focused ultrasound waves guided by MRI to create a lesion in the thalamus, disrupting abnormal electrical activity that causes tremors. DBS involves implanting electrodes in the thalamus or subthalamic area to deliver electrical pulses that modulate neural activity. Medications like beta-blockers and anticonvulsants reduce tremor amplitude by affecting neurotransmitter pathways. Understanding these mechanisms helps ET patients and their healthcare providers choose the most effective treatment based on the tremor's severity and characteristics.