RecruitingEarly Phase 1NCT07599592

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor

Sponsor

University of California, Los Angeles

Enrollment

20 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Essential Tremor

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

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 Criteria16

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.

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Interventions

DEVICELow 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.