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)