Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor (NCT07599592)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCLA Semel Institute for Neuroscience and Human Behavior โ Los Angeles, California
Age range: 18 Years to 90 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- UCLA Semel Institute for Neuroscience and Human Behavior โ Los Angeles, California
๐ Contact the Study Coordinator
Phone: (424) 371-9869
Email: andrewbishay@ucla.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Essential Tremor
- Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study โ Rochester, Minnesota
- Bilateral Treatment of Medication Refractory Essential Tremor โ Stanford, California
- Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET) โ Morgantown, West Virginia
- RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease โ Birmingham, Alabama
- Responsive Deep Brain Stimulator for Essential Tremor โ Gainesville, Florida
- Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders: โ Stanford, California
Explore by condition: All Essential Tremor clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.