Magnetoencephalography (MEG) Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI and fMRI scans, MEG, Sensor-based motor assessments, Clinical evaluations.
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: 50 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study
Overview
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.
Interventions
- 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 an - Other Clinical evaluations
vital signs, health status review, and neurological exam. - Other Questionnaires and rating scales that
daily functioning, mood, memory, and tremor
Primary outcome measures
- Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound [Time frame: baseline to 7 months]
Secondary outcome measures (12)
- Correlation between change in tremor amplitude and change in MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between change in tremor frequency and change in MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between change in gait parameters and change in MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between change in postural sway and change in MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between change in 360-degree turn performance and change in MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Change from Baseline in MEG-derived Functional Connectivity Strength [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Change from Baseline in MEG-derived Directed Connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Change from Baseline in MEG-derived Oscillatory Band Power [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Change from Baseline in MEG-derived Network Coherence [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between sonication energy and MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Baseline (pre-treatment) to 6 months post-treatment [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
- Correlation between number of sonications and MEG connectivity [Time frame: Baseline (pre-treatment) to 6 months post-treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UF Health — Gainesville
Identifiers
NCT: NCT07446192 · IRB202500103 · OCR48773