NCT07599592 · University of California, Los Angeles
Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
What this study is about
This where both patients and doctors know the treatment given pilot study will evaluate the safety, tolerability, feasibility, and preliminary effectiveness of repeated low-intensity focused ultrasound pulsation (LIFUP) targeting the ventral intermediate nucleus (Vim) of the thalamus in patients with Essential Tremor (ET).
View original scientific description
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.
Interventions
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.
Primary outcome measures
Accelerometric Data of Tremor Severity
Time frame: From enrollment until the end of treatment at 2 weeks
Accelerometric trackers will be used to quantify and track tremor severity at each study session.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- History of aneurysm
- History of cranial trauma resulting in fracture or traumatic brain injury
- Subjects who are unable to cooperate with the testing.
- Subjects who lack capacity to consent
- 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: i) 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 implanted medical devices
- Subjects with a history of seizure disorder.
- Subjects with contraindications to enter MRI environment
- Subjects with a history of substance abuse.
- Subjects who are currently pregnant. This will be verified by a urine test prior to beginning the study.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations