Magnetoencephalography (MEG) Pilot Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07446192
Status
Recruiting

Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
50 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI and fMRI scans — DIAGNOSTIC_TEST
    functional MRI, diffusion tensor imaging, anatomical MRI
  • MEG — DIAGNOSTIC_TEST
    non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.
  • Sensor-based motor assessments — DIAGNOSTIC_TEST
    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 — OTHER
    vital signs, health status review, and neurological exam.
  • Questionnaires and rating scales that — OTHER
    daily functioning, mood, memory, and tremor

Study Details

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.

Key Dates

Start date
Feb 17, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
UF HealthGainesvilleFlorida32610
Justin Hilliard, MD
352-273-9000

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