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RECRUITING
NCT07599592
EARLY_PHASE1

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Interventions

DEVICE

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