Ultrasound Neuromodulation for Essential Tremor (UNMET Trial)

N/A

Recruiting

Led By Leo Sugrue, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with medically refractory tremor scheduled to undergo MR-guided high-intensity focused ultrasound (HIFU) thalamotomy to treat their tremor at UCSF.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20-30 min mri scan at the end of the 3-4 hour experimental session

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study if low-intensity focused ultrasound (LIFU) can temporarily change brain activity and behavior when directed at specific parts of the brain. They will focus on areas associated with essential

Who is the study for?

This trial is for individuals with essential tremor, a condition causing involuntary shaking. Participants should be able to give informed consent and have no other neurological disorders or serious medical conditions that could interfere with the study.

What is being tested?

The study tests low-intensity focused ultrasound (LIFU) on parts of the brain linked to essential tremor. The goal is to see if LIFU can temporarily change brain activity and reduce tremors.

What are the potential side effects?

Potential side effects may include discomfort at the site of ultrasound application, headache, or temporary changes in sensation or mood due to brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a special ultrasound treatment at UCSF to manage my severe tremor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20-30 min mri scan at the end of the 3-4 hour experimental session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20-30 min mri scan at the end of the 3-4 hour experimental session

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20-30 min mri scan at the end of the 3-4 hour experimental session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in tremor tremor

Secondary study objectives

Changes in functional connectivity of brain networks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: To determine the most effective stimulation parameters for DRTT LIFU neuromodulation.Experimental Treatment2 Interventions

Investigators will record wrist accelerometer signals while participants maintain standardized postures that maximally elicit their tremor before, during, and after delivering LIFU stimulation.

0 / 1Eligibility criteria met