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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

Qualifiers

Confirmed clinical diagnosis of ET

Isolated tremor syndrome, at least 3 years duration

Subjective complaint of tremor assessed and validated by physician

Must be willing to comply with the study protocol

Disqualifiers

Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter.

Subjects on blood thinning medications (e.g. Eliquis)

Recent stroke (within the last 6 months)

Implanted electrodes (e.g. DBS) in brain

Trial design

Treatments tested in this trial

  • Low Intensity Focused Ultrasound (LIFU)

Treatment groups

20 Participants
are divided into 1 treatment group