Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07599592

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

Location status: Recruiting

Location contact

Andrew Bishay

CONTACT

[email protected]

4243719869

Ausaf Bari, MD, PhD

SUB_INVESTIGATOR

John Stern, MD

SUB_INVESTIGATOR

William Zeiger, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Intensity Focused Ultrasound (LIFU)

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Bishay

CONTACT

[email protected]

4243719869

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.