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.
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
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
Single group
Low Intensity Focused Ultrasound (LIFU)
DeviceParticipants 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.
Accelerometric Data of Tremor Severity
Accelerometric trackers will be used to quantify and track tremor severity at each study session.
TETRAS
The Essential Tremor Rating Scale is a clinically verified scale to track the severity of tremor.
Fahn-Tolosa-Marin Tremor Rating Scale
The Fahn-Tolosa-Marin Tremor Rating Scale is a clinically verified scale to track tremor severity.
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