Low Intensity Focused Ultrasound for Essential Tremor

Overseen By Andrew Bishay

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must not be taking: Blood thinners

Disqualifiers: Severe cardiac disease, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Low Intensity Focused Ultrasound (LIFU) to determine its effectiveness for people with Essential Tremor (ET), a condition causing uncontrollable shaking. The main goal is to assess the safety of this treatment and its ability to temporarily reduce tremors by targeting the thalamus, a specific part of the brain. Individuals diagnosed with ET for at least three years and experiencing bothersome tremors may be suitable candidates for this trial. Participants will undergo six treatment sessions over two weeks, followed by visits to monitor their progress. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

What prior data suggests that this low-intensity focused ultrasound is safe for essential tremor?

Research has shown that low-intensity focused ultrasound (LIFU) is generally safe and well-tolerated. Unlike high-intensity focused ultrasound, which can destroy tissue, LIFU causes reversible effects. This allows it to alter brain activity without causing lasting damage.

Studies have found that LIFU is usually safe, with few side effects. Any side effects that occur are often mild and resolve on their own. For example, one study reported only minor issues among participants, which resolved without treatment.

It is important to remember that this treatment is still under investigation. Scientists continue to study its safety, but early results are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Low Intensity Focused Ultrasound (LIFU) for Essential Tremor because it offers a non-invasive treatment option that could be safer and more targeted than current surgical options like deep brain stimulation. Unlike medications, which can cause side effects and may not be effective for everyone, LIFU uses sound waves to precisely target and disrupt the brain circuits responsible for tremors. This precision could lead to fewer side effects and a quicker recovery, making it a promising new approach for people with Essential Tremor.

What evidence suggests that low intensity focused ultrasound might be an effective treatment for Essential Tremor?

Research has shown that low-intensity focused ultrasound (LIFU) might greatly reduce essential tremor. In an earlier study, patients experienced a reduction in tremors by more than 89% after treatment. These improvements lasted for over 23 minutes, indicating that LIFU can temporarily alleviate tremor symptoms. The treatment uses sound waves to alter brain activity in areas related to tremors. Although more research is needed, these early results offer promise for people with essential tremor. ^{1 2 3 4 5}

Who Is on the Research Team?

William Zeiger, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with essential tremor who are willing to undergo repeated ultrasound treatments. Participants should not have conditions or implants that make MRI unsafe, and must be able to attend multiple sessions over about two weeks.

Inclusion Criteria

I have had isolated tremors for at least 3 years.

I am 90 years old or younger.

I have been diagnosed with essential tremor.

Exclusion Criteria

I have had a stroke in the past 6 months.

Subjects who are currently pregnant, verified by urine test prior to study start

Subjects with contraindications to enter MRI environment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo six LIFUP treatment sessions targeting the Vim of the thalamus over approximately two weeks

2 weeks

6 treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at one and three months post-treatment

3 months

Follow-up visits at 1 and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound (LIFU)

Trial Overview

The study tests whether low-intensity focused ultrasound (LIFU) targeting a brain area called the thalamus can safely reduce tremors in people with essential tremor. Each participant receives six LIFU sessions using the BrainSonix BX Pulsar 1002 system.

How Is the Trial Designed?

Group I: LIFU Open Label Group Experimental Treatment 1 Intervention

All subjects will be in the open-label arm of the study in which they will receive LIFU of the Vim

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X24000858

Sustained reduction of essential tremor with low-power non ...

Transcranial Ultrasound Stimulation induced more than 89 % reduction of essential tremor in 5 patients. •. A sustained effect (more than 23min) was observed in ...

2.

fusfoundation.org

fusfoundation.org/posts/essential-tremor-neuromodulation-clinical-trial-begins-in-california/

Essential Tremor Neuromodulation Clinical Trial Begins in ...

LIFU neuromodulation could be a useful tool for studying the brain circuits responsible for tremors and other brain disorders. Systematically ...

3.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06610877

Ultrasound Neuromodulation in Essential Tremor

This study is being done to test whether low-intensity focused ultrasound (LIFU) (low energy sound waves) cause temporary changes in brain activity and ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40351562/

High Intensity Focused Ultrasound - Longitudinal Data on ...

HiFU is an effective and generally well-tolerated treatment for tremor. Adverse events, especially gait instability, are typically temporary ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07484152

Motor and Non-Motor Effects of Low-Intensity Focused ...

This study investigates the motor and non-motor effects of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive neuromodulation technique in patients ...