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

NCT07599592 | Recruiting Early Phase 1 FDA Device

• 1 other identifier: LIFUP for ET_v8
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Keywords

Brainsonix; tFUS; Focused Ultrasound; Tremor; Movement Disorder

Outcome Measures

Primary Outcomes (1)

• Accelerometric Data of Tremor Severity

  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 Outcomes (2)

• TETRAS

  From enrollment to the end of treatment at 2 weeks.

• Fahn-Tolosa-Marin Tremor Rating Scale

  From enrollment to the end of treatment at 2 weeks.

Study Arms (1)

LIFU Open Label Group

EXPERIMENTAL

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)

Interventions

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.

Also known as: Transcranial Focused Ultrasound (tFUS)

LIFU Open Label Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

RECRUITING

Related Publications (18)

• Bishay AAED, Swenson AJ, Spivak NM, Schafer S, Bych BP, Gilles SD, Dorobczynski C, Korb AS, Schafer ME, Kuhn TP, Monti MM, Bystritsky A. Preliminary Examination of the Effects of Focused Ultrasound on Living Skin and Temperature at the Skin-Transducer Interface. Bioengineering (Basel). 2024 Nov 8;11(11):1126. doi: 10.3390/bioengineering11111126.

  PMID: 39593786 BACKGROUND

• Zesiewicz TA, Elble RJ, Louis ED, Gronseth GS, Ondo WG, Dewey RB Jr, Okun MS, Sullivan KL, Weiner WJ. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology. Neurology. 2011 Nov 8;77(19):1752-5. doi: 10.1212/WNL.0b013e318236f0fd. Epub 2011 Oct 19.

  PMID: 22013182 BACKGROUND

• Zeng Q, Guan X, Guo T, Law Yan Lun JCF, Zhou C, Luo X, Shen Z, Huang P, Zhang M, Cheng G. The Ventral Intermediate Nucleus Differently Modulates Subtype-Related Networks in Parkinson's Disease. Front Neurosci. 2019 Mar 11;13:202. doi: 10.3389/fnins.2019.00202. eCollection 2019.

  PMID: 30914916 BACKGROUND

• Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.

  PMID: 28150045 BACKGROUND

• Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.

  PMID: 34198105 BACKGROUND

• Spivak NM, Korb AS, Reyes SD, Bych BP, Schafer SF, Khanlou N, Johnson EA, Schafer ME, Cohen MS, Kuhn T, Bystritsky A. Histological examination of focused ultrasound effects on human brain tissue. Brain Stimul. 2021 Nov-Dec;14(6):1486-1488. doi: 10.1016/j.brs.2021.09.015. Epub 2021 Oct 1. No abstract available.

  PMID: 34607066 BACKGROUND

• Spivak NM, Bishay AAED, Haroon J, Hopkins AR, Tanabe J, Halavi S, Hoang-Dang B, Swenson AJ, Schafer SF, Schafer ME, Bystritsky A, Bookheimer SY, Monti MM. Dose-Escalation Study of Amygdalar Transcranial Focused Ultrasound in Healthy Volunteers. medRxiv [Preprint]. 2025 Oct 29:2025.10.21.25338018. doi: 10.1101/2025.10.21.25338018.

  PMID: 41282732 BACKGROUND

• Shanker V. Essential tremor: diagnosis and management. BMJ. 2019 Aug 5;366:l4485. doi: 10.1136/bmj.l4485.

  PMID: 31383632 BACKGROUND

• Schafer ME, Spivak NM, Korb AS, Bystritsky A. Design, Development, and Operation of a Low-Intensity Focused Ultrasound Pulsation (LIFUP) System for Clinical Use. IEEE Trans Ultrason Ferroelectr Freq Control. 2021 Jan;68(1):54-64. doi: 10.1109/TUFFC.2020.3006781. Epub 2020 Dec 23.

  PMID: 32746201 BACKGROUND

• Su JH, Choi EY, Tourdias T, Saranathan M, Halpern CH, Henderson JM, Pauly KB, Ghanouni P, Rutt BK. Improved Vim targeting for focused ultrasound ablation treatment of essential tremor: A probabilistic and patient-specific approach. Hum Brain Mapp. 2020 Dec;41(17):4769-4788. doi: 10.1002/hbm.25157. Epub 2020 Aug 6.

  PMID: 32762005 BACKGROUND

• Rohani M, Fasano A. Focused Ultrasound for Essential Tremor: Review of the Evidence and Discussion of Current Hurdles. Tremor Other Hyperkinet Mov (N Y). 2017 May 5;7:462. doi: 10.7916/D8Z89JN1. eCollection 2017.

  PMID: 28503363 BACKGROUND

• Owens-Walton C, Jakabek D, Power BD, Walterfang M, Velakoulis D, van Westen D, Looi JCL, Shaw M, Hansson O. Increased functional connectivity of thalamic subdivisions in patients with Parkinson's disease. PLoS One. 2019 Sep 4;14(9):e0222002. doi: 10.1371/journal.pone.0222002. eCollection 2019.

  PMID: 31483847 BACKGROUND

• Jankovic J, Aguilar LG. Current approaches to the treatment of Parkinson's disease. Neuropsychiatr Dis Treat. 2008 Aug;4(4):743-57. doi: 10.2147/ndt.s2006.

  PMID: 19043519 BACKGROUND

• Elias WJ, Lipsman N, Ondo WG, Ghanouni P, Kim YG, Lee W, Schwartz M, Hynynen K, Lozano AM, Shah BB, Huss D, Dallapiazza RF, Gwinn R, Witt J, Ro S, Eisenberg HM, Fishman PS, Gandhi D, Halpern CH, Chuang R, Butts Pauly K, Tierney TS, Hayes MT, Cosgrove GR, Yamaguchi T, Abe K, Taira T, Chang JW. A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med. 2016 Aug 25;375(8):730-9. doi: 10.1056/NEJMoa1600159.

  PMID: 27557301 BACKGROUND

• Deveney CM, Surya JR, Haroon JM, Mahdavi KD, Hoffman KR, Enemuo KC, Jordan KG, Becerra SA, Kuhn T, Bystritsky A, Jordan SE. Transcranial focused ultrasound for the treatment of tremor: A preliminary case series. Brain Stimul. 2024 Jan-Feb;17(1):35-38. doi: 10.1016/j.brs.2023.12.007. Epub 2023 Dec 19.

  PMID: 38128826 BACKGROUND

• Duval C, Daneault JF, Hutchison WD, Sadikot AF. A brain network model explaining tremor in Parkinson's disease. Neurobiol Dis. 2016 Jan;85:49-59. doi: 10.1016/j.nbd.2015.10.009. Epub 2015 Oct 14.

  PMID: 26459110 BACKGROUND

• Deuschl G, Raethjen J, Hellriegel H, Elble R. Treatment of patients with essential tremor. Lancet Neurol. 2011 Feb;10(2):148-61. doi: 10.1016/S1474-4422(10)70322-7.

  PMID: 21256454 BACKGROUND

• Chandran V, Pal PK. Essential tremor: beyond the motor features. Parkinsonism Relat Disord. 2012 Jun;18(5):407-13. doi: 10.1016/j.parkreldis.2011.12.003. Epub 2012 Jan 2.

  PMID: 22217558 BACKGROUND

MeSH Terms

Conditions

Essential Tremor; Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Zeiger, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Bishay

CONTACT

4243719869; andrewbishay@ucla.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open Label Pilot Study

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)