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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07599592
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Intensity Focused Ultrasound (LIFU) — DEVICE
    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.

Study Details

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 Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LIFU Open Label Group
    All subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim

Primary Outcome Measure

Accelerometric Data of Tremor Severity [ Time Frame: From enrollment until the end of treatment at 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Semel Institute for Neuroscience and Human BehaviorLos AngelesCalifornia90024
Andrew Bishay
[email protected]
4243719869
William Zeiger, MD, PhD (PRINCIPAL_INVESTIGATOR)
John Stern, MD (SUB_INVESTIGATOR)
Ausaf Bari, MD, PhD (SUB_INVESTIGATOR)

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By research site
UCLA Semel Institute for Neuroscience and Human Behavior· Los Angeles, CA

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