Gentle ultrasound pulses aimed at the brain for essential tremor
Tests repeated low-intensity focused ultrasound for safety in adults with essential tremor.
Key facts
- Who runs it
- University of California, Los Angeles
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Registry title
- Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 20 people, planned
- Started
- 1 May 2026
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Low Intensity Focused Ultrasound (LIFU)
- Record updated
- 20 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with essential tremor, a shaking condition. They will get 6 sessions of low intensity focused ultrasound aimed at a part of the brain.
- Age
- 18 Years to 90 Years
- Sex
- All sexes can join
- Disease stage
- Confirmed diagnosis of essential tremor. Tremor alone, lasting at least 3 years, with a tremor complaint checked by a doctor.
- Earlier treatment
- People with implanted brain electrodes (such as DBS) cannot join. People on blood thinning medicines (such as Eliquis) cannot join.
Main reasons for not taking part
- Severe small blood vessel disease or brain damage (Fazekas scale 3 or higher), stroke in the last 6 months, aneurysm, or past skull fracture or brain injury
- Severe heart disease, such as heart attack in the past 6 months or uncontrolled blood pressure (SBP >180 mmHg or DBP >110 mmHg)
- Any implanted medical device, use of a TENS unit, or unable to have an MRI
- History of seizures or substance abuse
- Currently pregnant (checked with a urine test)
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
- English Proficiency
- At least 18 years of age
- At most 90 years of age
Who cannot take part
- Subjects on blood thinning medications (e.g. Eliquis)
- Subjects who are currently pregnant. This will be verified by a urine test prior to beginning the study
- Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter
- Recent stroke (within the last 6 months)
- History of aneurysm
- History of cranial trauma resulting in fracture or traumatic brain injury
- Subjects with severe cardiac disease, increased intracranial pressure, or using a transcutaneous electrical nerve stimulation (TENS) unit
- Severe cardiac disease will be defined as any of the following:; History of myocardial infarction within the past 6 months ii) Diagnosis of congestive heart failure with NYHA 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
- Subjects with a history of seizure disorder
- Subjects with a history of substance abuse
- Implanted electrodes (e.g. DBS) in brain
- Subjects who are unable to cooperate with the testing
- Subjects who lack capacity to consent
- Subjects with implanted medical devices
- Subjects with contraindications to enter MRI environment
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in United States
- UCLA Semel Institute for Neuroscience and Human BehaviorLos Angeles, United StatesContact: Andrew BishayTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- LIFU Open Label GroupTreatment being tested
All subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim
Treatment: Low Intensity Focused Ultrasound (LIFU)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
- Plain-language title
- Gentle ultrasound pulses aimed at the brain for essential tremorGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07599592, who can take part
- Record updated
- 20 May 2026