NCT07599592 Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
| NCT ID | NCT07599592 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Los Angeles |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Confirmed clinical diagnosis of ET 2. Isolated tremor syndrome, at least 3 years duration 3. Subjective complaint of tremor assessed and validated by physician 4. Must be willing to comply with the study protocol 5. English Proficiency 6. At least 18 years of age 7. At most 90 years of age Exclusion Criteria: 1. Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter. 2. Subjects on blood thinning medications (e.g. Eliquis) 3. Recent stroke (within the last 6 months) 4. Implanted electrodes (e.g. DBS) in brain 5. History of aneurysm 6. History of cranial trauma resulting in fracture or traumatic brain injury 7. Subjects who are unable to cooperate with the testing. 8. Subjects who lack capacity to consent 9. Subjects with severe cardiac disease, increased intracranial pressure, or using a transcutaneous electrical nerve stimulation (TENS) unit. 10. 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 11. Subjects with implanted medical devices 12. Subjects with a history of seizure disorder. 13. Subjects with contraindications to enter MRI environment 14. Subjects with a history of substance abuse. 15. Subjects who are currently pregnant. This will be verified by a urine test prior to beginning the study.
Contact & Investigator
William Zeiger, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT07599592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07599592 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07599592 currently recruiting?
Yes, NCT07599592 is actively recruiting participants. Contact the research team at andrewbishay@ucla.edu for enrollment information.
Where is the NCT07599592 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07599592 clinical trial?
NCT07599592 is sponsored by University of California, Los Angeles. The principal investigator is William Zeiger, MD, PhD at University of California, Los Angeles. The trial plans to enroll 20 participants.