Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by William Zeiger, MD, PhD (ucla)
Headshot of William Zeiger
William Zeiger

Description

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.

Keywords

Essential Tremor, Brainsonix, tFUS, Focused Ultrasound, Tremor, Movement Disorder, Movement Disorders, Low Intensity Focused Ultrasound (LIFU)

Eligibility

You can join if…

Open to people ages 18-90

  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

You CAN'T join if...

  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

  1. Subjects with implanted medical devices
  2. Subjects with a history of seizure disorder.
  3. Subjects with contraindications to enter MRI environment
  4. Subjects with a history of substance abuse.
  5. Subjects who are currently pregnant. This will be verified by a urine test prior to beginning the study.

Location

  • UCLA Semel Institute for Neuroscience and Human Behavior accepting new patients
    Los Angeles California 90024 United States

Lead Scientist at University of California Health

  • William Zeiger, MD, PhD (ucla)
    William Zeiger, M.D., Ph.D., holds the Howard and Irene Levine Family Term Chair for Excellence in Movement Disorders Research. Dr. Zeiger is a physician scientist in the Department of Neurology at UCLA. Clinically, He works as a neurologist specializing in movement disorders, particularly Parkinson disease and atypical parkinsonian disorders.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07599592
Phase
Phase 1 Essential Tremor Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated