Recruiting
Early Phase 1

LIFUP

Sponsor:

UCLA

Code:

NCT07599592

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low Intensity Focused Ultrasound (LIFU)

Study Details

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.

Conditions

Essential Tremor

Study ID

NCT07599592

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LIFU Open Label Group

All subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim

Interventions

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 measure

  • Accelerometric Data of Tremor Severity [ Time Frame: From enrollment until the end of treatment at 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

UCLA Semel Institute for Neuroscience and Human Behavior

Recruiting

Los Angeles, California, United States, 90024

Contacts

Principal Investigator:

William Zeiger, MD, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • Brainsonix
  • tFUS
  • Focused Ultrasound
  • Tremor
  • Movement Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.