Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study
University of Florida
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.
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.
Eligibility
- Age range
- 50–84 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- Diagnostic TestMRI and fMRI scans
functional MRI, diffusion tensor imaging, anatomical MRI
- Diagnostic TestMEG
non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.
- Diagnostic TestSensor-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.
- OtherClinical evaluations
vital signs, health status review, and neurological exam.
- OtherQuestionnaires and rating scales that
daily functioning, mood, memory, and tremor
Location
- UF HealthGainesville, Florida