High-Intensity Focused Ultrasound for Essential Tremor
(MEG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how High-Intensity Focused Ultrasound (HiFU) can assist individuals with essential tremor, a condition causing uncontrollable shaking, usually in the hands. The goal is to assess how this treatment affects brain networks using safe tests like brain scans and movement assessments. HiFU targets a specific brain area with sound waves to reduce tremors. Individuals whose essential tremor has not improved with at least two different medications might be suitable candidates for this trial.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since it mentions that participants should be refractory (not responding) to at least two first-line tremor medications, you might be expected to continue your current treatment.
What prior data suggests that High-Intensity Focused Ultrasound is safe for treating essential tremor?
Research has shown that High-Intensity Focused Ultrasound (HiFU) generally provides a safe treatment for essential tremor. Studies have found that most patients tolerate this treatment well. Side effects, such as difficulty walking steadily, are usually temporary. Most patients notice immediate improvement in their tremors and can return home the same day. Overall, HiFU offers an effective, non-surgical treatment option that has been successfully used for essential tremor and even tremors from Parkinson's disease.12345
Why are researchers excited about this trial?
High-Intensity Focused Ultrasound (HiFU) is unique because it offers a non-invasive approach to treating essential tremor, a condition often managed with medications like beta-blockers and anticonvulsants. Unlike these standard treatments, which can have systemic side effects and varying effectiveness, HiFU precisely targets and destroys the brain tissue causing the tremor without requiring surgery. Researchers are excited about HiFU because it provides a targeted treatment option that could lead to rapid symptom relief and improved quality of life for patients who don't respond to traditional medications.
What evidence suggests that High-Intensity Focused Ultrasound is effective for essential tremor?
Research has shown that High-Intensity Focused Ultrasound (HiFU), the treatment under study in this trial, effectively addresses essential tremor, a condition causing uncontrollable shaking. Studies have found that 33% of patients experience complete relief from tremors, while 47% see their tremors reduced by 50-99%. Overall, tremor improvement rates range from 50 to 75%, with benefits lasting up to five years. This treatment is generally well-tolerated, although some patients may temporarily have trouble walking. Overall, HiFU provides significant and lasting relief for many people with essential tremor.12367
Who Is on the Research Team?
Justin Hilliard, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for people aged 50 to under 85 with essential tremor that hasn't improved after trying at least two standard medications. Participants must not have certain implants, severe depression or anxiety, major memory problems, or head tremors that would interfere with brain scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment Assessment
Participants undergo assessments including MRI, fMRI, MEG recordings, and sensor-based motor assessments before treatment
Treatment
Participants receive High-Intensity Focused Ultrasound (HiFU) treatment
Post-Treatment Monitoring
Participants are monitored with MEG, fMRI, and sensor-based assessments at multiple time points after treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- High-Intensity Focused Ultrasound (HiFU)
Trial Overview
Researchers are using non-invasive tests like MEG (brain wave recordings), MRI/fMRI scans, movement assessments, and questionnaires to study how the brain changes in people with essential tremor before and after treatment with High-Intensity Focused Ultrasound (HiFU).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
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 ...
High Intensity Focused Ultrasound – Longitudinal Data on ...
Among these 15 patients, 5 (33%) achieved complete tremor resolution following HIFU, while 7 (47%) showed a 50–99% reduction in tremor severity.
High-intensity focused ultrasound (HIFU) versus deep brain ...
Tremor improvement rates range from 50 to 75% for ET and 60 to 90% for tremor-dominant PD, with long-term efficacy sustained up to 5 years ...
4.
fusfoundation.org
fusfoundation.org/posts/focused-ultrasound-and-stroke-results-from-two-recent-clinical-trials/Results from Two Recent Clinical Trials
Recent clinical trials investigated two interesting focused ultrasound approaches for addressing the treatment of stroke.
RESULTS - Comparative Effectiveness of Focused Ultrasound ...
Finally, the study reported that head tremor scores improved at 3 months (MD = −0.70, 95% CI [−0.95, −0.45]) and 12 months (MD = −0.90, 95% CI [−1.07, −0.73]) ...
6.
researchgate.net
researchgate.net/publication/391453455_High_Intensity_Focused_Ultrasound_-Longitudinal_Data_on_Efficacy_and_Safety(PDF) High Intensity Focused Ultrasound -Longitudinal ...
High intensity focused ultrasound (HiFU) is a relatively new incisionless intervention used for treatment of essential tremor and Parkinson's disease tremor.
High-Intensity Focused Ultrasound (HIFU)
Most patients who receive focused ultrasound treatment see an immediate improvement in their tremors. // Sample of improvement. Individual results vary. Is ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.