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

May 14, 2026 updated by: William Zeiger, MD, PhD, University of California, Los Angeles
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • Recruiting
        • UCLA Semel Institute for Neuroscience and Human Behavior
        • Contact:
        • Principal Investigator:
          • William Zeiger, MD, PhD
        • Sub-Investigator:
          • John Stern, MD
        • Sub-Investigator:
          • Ausaf Bari, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Transcranial Focused Ultrasound (tFUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment until the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TETRAS
Time Frame: From enrollment to the end of treatment at 2 weeks.
The Essential Tremor Rating Scale is a clinically verified scale to track the severity of tremor.
From enrollment to the end of treatment at 2 weeks.
Fahn-Tolosa-Marin Tremor Rating Scale
Time Frame: From enrollment to the end of treatment at 2 weeks.
The Fahn-Tolosa-Marin Tremor Rating Scale is a clinically verified scale to track tremor severity.
From enrollment to the end of treatment at 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: William Zeiger, MD, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIFUP for ET_v8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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