Recruiting

HiFU

Sponsor:

University of Florida

Code:

NCT07446192

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI and fMRI scans

MEG

Sensor-based motor assessments

Clinical evaluations

Questionnaires and rating scales that

Study Details

Brief 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.

Conditions

Essential Tremor

Study ID

NCT07446192

Start date

Feb 17, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion:

  • Age >50 years and <85 years
  • Refractory to at least 2 first line tremor medications
  • Skull Density Ratio (SDR) > = 0.35

Exclusion:

  • MR/MEG incompatible implants and implantable devices (ex: pacemaker)
  • Head tremor interfering with MEG recording
  • Severe depression and/or anxiety
  • Severe cognitive impairment

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Essential Tremor refractory to at least 2 first line tremor medications

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.

Interventions

MRI and fMRI scans

functional MRI, diffusion tensor imaging, anatomical MRI

MEG

non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.

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.

Clinical evaluations

vital signs, health status review, and neurological exam.

Questionnaires and rating scales that

daily functioning, mood, memory, and tremor

Primary outcome measure

  • Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound [ Time Frame: baseline to 7 months ]

Central Contacts and Locations

Central contacts

Kerstin Rodriguez, CCMA, CPT

352-273-9000Kerstin.Rodriguez@neurosurgery.ufl.edu

Locations

UF Health

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Justin Hilliard, MD

352-273-9000

More Information

Sponsor

University of Florida

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Florida on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.