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Essential TremorEarly Phase 1NCT07599592

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

A Early Phase 1 study testing Low Intensity Focused Ultrasound (LIFU) in people with Essential Tremor, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Essential Tremor
What is being tested?
Low Intensity Focused Ultrasound (LIFU)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 May 2026to 1 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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:
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Bishay contact

4243719869

andrewbishay@ucla.edu

United States1 site, 1 recruiting

  • UCLA Semel Institute for Neuroscience and Human Behavior

    Los Angeles, California, 90024

    Andrew Bishay, 4243719869, andrewbishay@ucla.edu

    William Zeiger, MD, PhD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Low Intensity Focused Ultrasound (LIFU)
Keywords
Brainsonix, tFUS, Focused Ultrasound, Tremor, Movement Disorder
Medical subject headings
Essential Tremor, Tremor, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Intensity Focused Ultrasound (LIFU)Device

    Also called Transcranial Focused Ultrasound (tFUS)

    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.

Study groups in NCT07599592
Study groupRoleWhat they receive
LIFU Open Label GroupExperimentalAll subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim
Receives: Device: Low Intensity Focused Ultrasound (LIFU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accelerometric Data of Tremor Severity

    Accelerometric trackers will be used to quantify and track tremor severity at each study session.

    Measured: From enrollment until the end of treatment at 2 weeks

Secondary outcomes (2)

  1. TETRAS

    The Essential Tremor Rating Scale is a clinically verified scale to track the severity of tremor.

    Measured: From enrollment to the end of treatment at 2 weeks.

  2. Fahn-Tolosa-Marin Tremor Rating Scale

    The Fahn-Tolosa-Marin Tremor Rating Scale is a clinically verified scale to track tremor severity.

    Measured: From enrollment to the end of treatment at 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start1 May 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label Pilot Study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07599592
Sponsor's protocol ID
LIFUP for ET_v8
Status last verified
May 2026
First submitted
14 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39593786

  • 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.

    PubMed 22013182

  • 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.

    PubMed 30914916

  • 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.

    PubMed 28150045

  • 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.

    PubMed 34198105

  • 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.

    PubMed 34607066

  • 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.

    PubMed 41282732

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

    PubMed 31383632

  • 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.

    PubMed 32746201

  • 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.

    PubMed 32762005

  • 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.

    PubMed 28503363

  • 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.

    PubMed 31483847

  • 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.

    PubMed 19043519

  • 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.

    PubMed 27557301

  • 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.

    PubMed 38128826

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Low Intensity Focused Ultrasound (LIFU) in people with Essential Tremor, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Bishay (4243719869, andrewbishay@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accelerometric Data of Tremor Severity (time frame: From enrollment until the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07599592, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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