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NCT Number: NCT07446192

Magnetoencephalography (MEG) Pilot Study

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

50 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Justin Hilliard, MD

CONTACT

352-273-9000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound

    Time frame: baseline to 7 months

    Brain electrical activity will be recorded using magnetoencephalography (MEG) before treatment and at follow-up visits after treatment. MEG signals are collected as time-series data and processed to derive quantitative measures of functional brain connectivity that inform how interconnected different brain regions are. The primary outcome is the average change in these connectivity measures from pre-treatment baseline to post-treatment follow-up across participants.

Secondary outcomes

  1. Correlation between change in tremor amplitude and change in MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived tremor amplitude (acceleration magnitude, m/s2) and the change in MEG connectivity metrics.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  2. Correlation between change in tremor frequency and change in MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived tremor frequency (Hz) and the change in MEG connectivity metrics.

    Correlation coefficient (r) ranging from -1 to 1

  3. Correlation between change in gait parameters and change in MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the correlation between the change in wearable sensor-derived gait parameters during a standardized walk test and the change in MEG connectivity metrics.

    Correlation coefficient (r) ranging from -1 to 1

  4. Correlation between change in postural sway and change in MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the correlation between the change in wearable balance sensor-derived postural sway and the change in MEG connectivity metrics.

    Correlation coefficient (r) ranging from -1 to 1

  5. Correlation between change in 360-degree turn performance and change in MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the correlation between the change in 360-degree turn performance (duration and number of steps), obtained from wearable sensors, and the change in MEG connectivity metrics.

    Correlation coefficient (r) ranging from -1 to 1

  6. Change from Baseline in MEG-derived Functional Connectivity Strength

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Assessment of the longitudinal change in MEG-derived functional connectivity strength over multiple time points.

    Unitless connectivity coefficient, reported as Z-score difference

  7. Change from Baseline in MEG-derived Directed Connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Assessment of the longitudinal change in MEG-derived directed (effective) connectivity over multiple time points.

    Unitless influence coefficient, reported as Z-score difference

  8. Change from Baseline in MEG-derived Oscillatory Band Power

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Assessment of the longitudinal change in MEG-derived oscillatory band (delta, theta, alpha, beta, gamma) power over multiple time points.

    Unit of Measure: fT²/Hz, reported as average of differences

  9. Change from Baseline in MEG-derived Network Coherence

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Assessment of the longitudinal change in MEG-derived network coherence over multiple time points.

    Unit of Measure: Unitless coherence index, reported as Z-score difference

  10. Correlation between sonication energy and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between total sonication energy (Joules, J) and MEG-derived network measures including functional connectivity strength, directed connectivity, oscillatory band power, and network coherence.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  11. Baseline (pre-treatment) to 6 months post-treatment

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between peak intra-procedural temperature (degrees Celsius, °C) and MEG-derived network measures including functional connectivity strength, directed connectivity, oscillatory band power, and network coherence.

    Correlation coefficient (r) ranging from -1 to 1

  12. Correlation between number of sonications and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between the total number of sonications (count) and MEG-derived functional connectivity strength

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  13. Correlation between lesion volume and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between lesion volume (cubic millimeters, mm³) and MEG-derived functional connectivity strength

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  14. Correlation between patient age and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between patient age (years) and MEG-derived functional connectivity strength

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  15. Correlation between disease duration and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between disease duration (years) and MEG-derived functional connectivity strength

    Correlation coefficient (r) ranging from -1 to 1

  16. Correlation between change from baseline in CRST score and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in tremor severity as measured by the Clinical Rating Scale for Tremor (CRST score, points) and MEG-derived functional connectivity strength.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  17. Correlation between change from baseline in tremor amplitude and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in wearable sensor-derived tremor amplitude (acceleration magnitude, m/s²) and MEG-derived functional connectivity strength.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  18. Correlation between change from baseline in tremor frequency and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in tremor frequency (Hertz, Hz), measured using a wearable sensor and MEG-derived functional connectivity strength.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  19. Correlation between change from baseline in gait speed and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in gait speed (meters per second, m/s) during a standardized walk test, obtained using wearable sensors and MEG-derived functional connectivity strength.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  20. Correlation between change from baseline in postural sway and MEG connectivity

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in postural sway (acceleration magnitude, m/s²) from wearable sensors and MEG-derived functional connectivity strength.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

  21. Correlation between change from baseline in 360-degree turn performance and MEG-derived functional connectivity strength.

    Time frame: Baseline (pre-treatment) to 6 months post-treatment

    Pearson correlation coefficient evaluating the relationship between change from baseline in 360-degree turn duration (seconds) and number of steps (count) from wearable sensors, and MEG-derived network measures.

    Unit of Measure: Correlation coefficient (r) ranging from -1 to 1

Study contacts

Contact information is provided by the study sponsor or research team.

subeikshanan venkatesan, MBBS

CONTACT

[email protected]

352-273-9000

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: MEG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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