An Early Phase 1 interventional study of Low Intensity Focused Ultrasound (LIFU) in Essential Tremor, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Treatment
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.
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's planned enrollment of 20 is below the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Severe cardiac disease will be defined as any of the following:
i) History of myocardial infarction within the past 6 months ii) Diagnosis of congestive heart failure with Class III or IV symptoms iii) History of unstable angina, life-threatening arrhythmias, or use of an implantable cardioverter-defibrillator (ICD) iv) Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg) despite medication v) Any condition judged by the study physician to place the subject at increased risk from study participation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim
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.
Also known as: Transcranial Focused Ultrasound (tFUS)
Accelerometric Data of Tremor Severity
Accelerometric trackers will be used to quantify and track tremor severity at each study session.
Time frame: From enrollment until the end of treatment at 2 weeks
TETRAS
The Essential Tremor Rating Scale is a clinically verified scale to track the severity of tremor.
Time frame: From enrollment to the end of treatment at 2 weeks.
Fahn-Tolosa-Marin Tremor Rating Scale
The Fahn-Tolosa-Marin Tremor Rating Scale is a clinically verified scale to track tremor severity.
Time frame: From enrollment to the end of treatment at 2 weeks.
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
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