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

Recruiting in Palo Alto (17 mi)

Overseen ByAndres Lozano, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

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.

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.

+2 more

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.

+1 more

Participant Groups

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.

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).