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 wil
| Condition(s) | Essential Tremor |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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. Th |
| Who can participate | 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 |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | University of California, Los Angeles |
| Locations | Los Angeles, California, United States |
| Start date | 2026-05-01 |
| NCT ID | NCT07599592 |
| Official listing | https://clinicaltrials.gov/study/NCT07599592 |