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

19 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for essential tremor?

Research shows that magnetic resonance-guided focused ultrasound thalamotomy is effective and safe for treating essential tremor, with studies demonstrating its long-term effectiveness and minimal side effects over several years. ^{1 2 3 4 5}

Is focused ultrasound thalamotomy safe for humans?

Research shows that focused ultrasound thalamotomy, guided by MRI, is generally safe for treating essential tremor, with studies following patients for up to 5 years without significant adverse effects. ^{1 4 5 6 7}

How is the treatment Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy unique for essential tremor?

This treatment is unique because it uses focused ultrasound waves guided by MRI to target and treat the brain area responsible for tremors without needing invasive surgery, making it a safer and effective option for those who do not respond to medication. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Research Team

Andres Lozano, MD, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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.

My doctor has advised against me joining this trial.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Resonance-Guided Focused Ultrasound Thalamotomy in Essential Tremor: A Comprehensive Lesion Characterization. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: a 5-year single-center experience. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor: 5-year follow-up results. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Four-year follow-up results of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes and Predictive Factors following Focused Ultrasound Thalamotomy for Essential Tremor. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Bilateral Radiofrequency Ventral Intermediate Thalamotomy for Essential Tremor. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Bilateral staged magnetic resonance-guided focused ultrasound thalamotomy for the treatment of essential tremor: a case series study. [2022]