Actively Recruiting
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
Eligibility Criteria
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.
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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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