Focused Ultrasound Thalamotomy for Essential Tremor

(BEST-FUS Trial)

Overseen By Christian Iorio-Morin, M.D. Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Gait impairment, Speech impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores Magnetic Resonance-guided Focused Ultrasound thalamotomy for individuals with essential tremor, a condition that causes shaky hands. The trial tests this procedure on the opposite side of the brain in patients who have already experienced success with it on one side. It evaluates any side effects and improvements in daily life and tremor control. Ideal candidates are those who have undergone this procedure before, have bothersome tremors on the untreated side, and seek treatment for that side. As an unphased trial, it offers a unique opportunity for patients to further enhance their quality of life by addressing tremors on the untreated side.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this focused ultrasound thalamotomy is safe for essential tremor?

Research has shown that Magnetic Resonance-guided Focused Ultrasound (MRgFUS) thalamotomy is generally safe for treating essential tremor. Studies following patients for several years indicate that this treatment significantly reduces tremors and improves quality of life.

In one study, researchers monitored patients who underwent MRgFUS thalamotomy for up to five years. These patients experienced lasting improvements in their tremor symptoms. Importantly, the treatment was well-tolerated, with most individuals not experiencing severe side effects.

Another study examined the safety of performing this procedure on both sides of the brain, known as bilateral treatment. The results suggested that this approach is also safe and can be done without major issues.

While side effects can occur, they are usually mild and temporary, such as slight numbness or tingling. Serious problems are rare. Overall, evidence suggests that MRgFUS thalamotomy is a safe option for people with essential tremor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Magnetic Resonance-guided Focused Ultrasound (MRgFUS) VIM Thalamotomy because it offers a non-invasive alternative to traditional treatments like medication, deep brain stimulation, or surgical thalamotomy for Essential Tremor. This technique uses focused ultrasound waves to precisely target and ablate the area of the brain responsible for tremors without the need for incisions. The use of real-time MRI guidance allows for high precision, potentially reducing side effects and recovery time compared to invasive surgeries. This new approach could provide a safer, more comfortable option for patients who have not responded well to existing treatments.

What evidence suggests that Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy is effective for essential tremor?

Research has shown that Magnetic Resonance-guided Focused Ultrasound (MRgFUS) thalamotomy, which participants in this trial will undergo, effectively treats essential tremor. Studies have found that patients often experience a significant reduction in tremors, with benefits lasting up to five years. Many patients also report improved quality of life after the procedure. This treatment is well-established and has been successfully used in numerous cases. Overall, MRgFUS thalamotomy offers a promising option for those with essential tremor seeking symptom relief. ^{1 3 4 6 7}

Who Is on the Research Team?

Andres Lozano, MD, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I want treatment for the opposite side of my initial condition.

My tremor on one side is affecting my daily life.

I have been diagnosed with Essential Tremor by a specialist.

Exclusion Criteria

I have trouble being understood when I speak.

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

Inability to comply with the follow-up schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a contralateral thalamotomy using MRgFUS

Immediate procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for side effects and initial outcomes

3 months

3 visits (in-person) at 1, 3 months post-operatively

Extended Follow-up

Participants are monitored for long-term outcomes and quality of life

36 months

Visits at 12, 24, and 36 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38737350/

Magnetic resonance-guided focused ultrasound unilateral ... We present data on 49 consecutive cases of MRgFUS Vim thalamotomy followed-up for 3 years and review the literature on studies with longer follow-up data.

2. thejns.org thejns.org/view/journals/j-neurosurg/138/4/article-p1028.xml

5-year follow-up results in - Journal of Neurosurgery Unilateral MRgFUS thalamotomy demonstrates sustained and significant tremor improvement at 5 years with an overall improvement in quality-of-life measures.

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/full/10.1002/mds.30188

Efficacy and Safety of Magnetic Resonance‐Guided Focused ... Magnetic resonance-guided focused ultrasound (MRgFUS) is an established surgical treatment for essential tremor, providing tremor relief ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1360035/full

Magnetic resonance-guided focused ultrasound unilateral ... We present data on 49 consecutive cases of MRgFUS Vim thalamotomy followed-up for 3 years and review the literature on studies with longer follow-up data.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07006740

Safety and Effectiveness of Unilateral MR-Guided Focused ... This study is a multicenter, non-randomized controlled observational study designed to evaluate the safety and effectiveness of unilateral MRgFUS thalamotomy ...

6. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29801

Magnetic Resonance‐Guided Focused Ultrasound (MRgFUS ... Factors predicting clinical outcomes after MR-guided focused ultrasound (MRgFUS)-thalamotomy in patients with essential tremor (ET) are not well known.

7. academic.oup.com academic.oup.com/braincomms/article/7/3/fcaf168/8123806

Safety and efficacy of bilateral staged focused ultrasound ... This study evaluates the efficacy and safety of bilateral staged Magnetic Resonance Imaging-guided High-Intensity Focused Ultrasound thalamotomy ...