High-Intensity Focused Ultrasound for Essential Tremor

(MEG Trial)

Overseen By subeikshanan venkatesan, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Implants, Head tremor, Severe depression, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to learn more about how the brain works in people with essential tremor, and how it changes after treatment with High-Intensity Focused Ultrasound (HiFU). Essential tremor is a movement disorder that causes shaking, usually in the hands, and can make everyday tasks difficult. HiFU is a treatment that uses focused sound waves to target a small area in the brain involved in tremor. In this study, the investigators aim to understand how this treatment affects the brain's networks by using safe, non-invasive tests such as brain imaging, brain wave recordings, and movement assessments.

Who Is on the Research Team?

Justin Hilliard, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Inclusion Criteria

My tremor did not improve after trying at least two first-line medications.

* Skull Density Ratio (SDR) \> = 0.35

* MR/MEG incompatible implants and implantable devices (ex: pacemaker)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Treatment Assessment

Participants undergo assessments including MRI, fMRI, MEG recordings, and sensor-based motor assessments before treatment

1 week

1 visit (in-person)

Treatment

Participants receive High-Intensity Focused Ultrasound (HiFU) treatment

1 day

1 visit (in-person)

Post-Treatment Monitoring

Participants are monitored with MEG, fMRI, and sensor-based assessments at multiple time points after treatment

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Focused Ultrasound (HiFU)

How Is the Trial Designed?

Group I: Essential Tremor refractory to at least 2 first line tremor medications Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+