NCT07446192

Magnetoencephalography (MEG) Pilot Study

Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 50 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participation in this study will last for approximately eight months. Participants will be asked to attend a total of six study visits. These include a screening visit to see if a potential participant qualifies for the study, an assessment visit before treatment and treatment visits. Prior to and after treatment (one day, six weeks, and six months after treatment), participants will have Magnetoencephalography (MEG), Functional Magnetic Resonance Imaging (fMRI), Sensor-Based Gait and Motor Function Assessments and Self-Report Questionnaires.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI and fMRI scans	functional MRI, diffusion tensor imaging, anatomical MRI
DIAGNOSTIC_TEST	MEG	non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.
DIAGNOSTIC_TEST	Sensor-based motor assessments	research-grade wearable sensors equipped with gyroscopes and accelerometers to precisely and accurately quantify patients' tremors. These sensors will be worn on the wrist or finger, capturing data as patients perform standardized tremor assessment tasks, such as spiral drawing task, writing task, commonly used in essential tremor evaluation. Gait and balance assessments will be conducted by synchronizing multiple sensors placed on the upper and lower extremities as well as the midline. Gait and balance data will be collected during tasks such as the 7-meter walk test, 360-degree turn test, and postural sway.
OTHER	Clinical evaluations	vital signs, health status review, and neurological exam.
OTHER	Questionnaires and rating scales that	daily functioning, mood, memory, and tremor

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-03-03
• Last updated: 2026-03-03