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Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
Sponsor: University of California, Los Angeles
Summary
This open-label pilot study will evaluate the safety, tolerability, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound pulsation (LIFUP) targeting the ventral intermediate nucleus (Vim) of the thalamus in patients with Essential Tremor (ET). Twelve adults with clinically diagnosed ET will undergo six LIFUP treatment sessions over approximately two weeks using the BrainSonix BX Pulsar 1002 system. Tremor severity will be assessed using clinician-rated scales (TETRAS and FTM), patient-reported quality-of-life measures (QUEST), and objective accelerometry before and after treatment sessions, with additional follow-up visits at one and three months post-treatment. MRI scans will be performed at baseline and after the final treatment session to monitor safety. The study aims to characterize whether non-ablative focused ultrasound can safely and transiently modulate tremor-related thalamic circuits and provide preliminary evidence supporting future controlled trials of LIFUP for ET.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-01
Completion Date
2027-06-01
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
Low Intensity Focused Ultrasound (LIFU)
Participants will receive low-intensity focused ultrasound pulsation (LIFUP) delivered using the BrainSonix BX Pulsar 1002 investigational device targeting the ventral intermediate nucleus (Vim) of the thalamus.
Locations (1)
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States