Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06610877

Ultrasound Neuromodulation in Essential Tremor

Led by University of California, San Francisco · Updated on 2026-03-06

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

F

Focused Ultrasound Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether low-intensity focused ultrasound (LIFU), which uses low energy sound waves, can temporarily change brain activity and improve symptoms in people with essential tremor (ET). This study focuses on targeting LIFU to a specific brain circuit called the dentatorubrothalamic tract (DRTT), which is thought to be responsible for ET. The goal is to find the best ultrasound settings to reduce tremor and to understand how these changes affect brain networks. This research is interventional and uses repeated measures within the same participants. Participants will undergo a single LIFU session lasting about 3 to 4 hours, typically one or two days before their scheduled MR-guided high-intensity focused ultrasound (HIFU) treatment for tremor. During the session, researchers will apply multiple brief ultrasound stimulations with varying settings while measuring tremor using wrist accelerometers. A sham stimulation using unfocused ultrasound will also be done to control for non-specific effects. After the stimulation session, brain scans using resting state functional MRI will assess changes in brain connectivity. Participants will then proceed with their planned HIFU treatment, which includes similar tremor monitoring and MRI evaluations. Throughout the study, participants will have their tremor severity recorded before, during, and after each ultrasound stimulation. The research team will analyze these measurements to identify the stimulation settings that most effectively reduce tremor temporarily. Functional brain changes will be examined through MRI scans taken shortly after the LIFU session. The study monitors safety and treatment effects during the same visit, and participation lasts for the duration of the LIFU session plus follow-up imaging and the subsequent HIFU procedure.

CONDITIONS

Brief Title

Ultrasound Neuromodulation in Essential Tremor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with medically refractory tremor scheduled to undergo MR-guided high-intensity focused ultrasound (HIFU) thalamotomy to treat their tremor at UCSF.
Not Eligible

You will not qualify if you...

  • Patients with pacemakers are excluded due to MRI and monitoring complexities. All other patients undergoing HIFU thalamotomy for tremor are eligible for enrollment.

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 to 4 hours

Participants undergo a single session of low-intensity focused ultrasound neuromodulation (LIFU) lasting 3-4 hours to test different stimulation parameters and measure effects on essential tremor using wrist accelerometers. The session includes up to 25 repeated 60-second stimulation protocols with rest periods, a sham stimulation, and a final active stimulation followed by a brief MRI scan to assess brain connectivity changes.

1 extended visit (in-person)

Treatment

Duration - Single procedure day plus post-treatment observation

Participants proceed with their scheduled MR-guided high-intensity focused ultrasound (HIFU) thalamotomy treatment for essential tremor, including wrist accelerometer measurements during the procedure and post-treatment MRI assessments.

1 treatment visit and approximately 1 follow-up imaging visit

Trial Site Locations

Total: 1 location

1

Pritzker Building, UCSF

San Francisco, California, United States, 94107

Actively Recruiting

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Research Team

L

Leo P. Sugrue, MD, PhD

T

Tommaso Di Ianni, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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