Essential TremorMEGNCT07446192
Magnetoencephalography (MEG) Pilot Study
A study testing MRI and fMRI scans, MEG and Sensor-based motor assessments in people with Essential Tremor, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- MRI and fMRI scans, MEG and Sensor-based motor assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years and <85 years
- Refractory to at least 2 first line tremor medications
- Skull Density Ratio (SDR) > = 0.35
Who cannot join
- MR/MEG incompatible implants and implantable devices (ex: pacemaker)
- Head tremor interfering with MEG recording
- Severe depression and/or anxiety
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health
Gainesville, Florida, 32610
Justin Hilliard, MD, 352-273-9000
About this study
Official title: Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a 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.
Read the 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.
- Conditions
- Essential Tremor
- Being tested
- MRI and fMRI scans, MEG, Sensor-based motor assessments, Clinical evaluations, Questionnaires and rating scales that
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and fMRI scansDiagnostic test
functional MRI, diffusion tensor imaging, anatomical MRI
MEGDiagnostic test
non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.
Sensor-based motor assessmentsDiagnostic 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 evaluationsOther
vital signs, health status review, and neurological exam.
Questionnaires and rating scales thatOther
daily functioning, mood, memory, and tremor
| Study group | Role | What they receive |
|---|---|---|
| Essential Tremor refractory to at least 2 first line tremor medications | Experimental | 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. Receives: Diagnostic Test: MRI and fMRI scans; Diagnostic Test: MEG; Diagnostic Test: Sensor-based motor assessments; Other: Clinical evaluations; Other: Questionnaires and rating scales that |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound
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.
Measured: baseline to 7 months
Secondary outcomes (21)
Correlation between change in tremor amplitude and change in MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change in tremor frequency and change in MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change in gait parameters and change in MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change in postural sway and change in MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change in 360-degree turn performance and change in MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Change from Baseline in MEG-derived Functional Connectivity Strength
Assessment of the longitudinal change in MEG-derived functional connectivity strength over multiple time points.
Unitless connectivity coefficient, reported as Z-score difference
Measured: Baseline (pre-treatment) to 6 months post-treatment
Change from Baseline in MEG-derived Directed Connectivity
Assessment of the longitudinal change in MEG-derived directed (effective) connectivity over multiple time points.
Unitless influence coefficient, reported as Z-score difference
Measured: Baseline (pre-treatment) to 6 months post-treatment
Change from Baseline in MEG-derived Oscillatory Band Power
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Change from Baseline in MEG-derived Network Coherence
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between sonication energy and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between number of sonications and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between lesion volume and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between patient age and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between disease duration and MEG connectivity
Pearson correlation coefficient evaluating the relationship between disease duration (years) and MEG-derived functional connectivity strength
Correlation coefficient (r) ranging from -1 to 1
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in CRST score and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in tremor amplitude and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in tremor frequency and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in gait speed and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in postural sway and MEG connectivity
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in 360-degree turn performance and MEG-derived functional connectivity strength.
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
Measured: Baseline (pre-treatment) to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start17 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Hilliard, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446192
- Sponsor's protocol ID
- IRB202500103
- Other IDs
- OCR48773
- Acronym
- MEG
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study
- ClinicalTrials.gov ID
- NCT07446192
- Acronym / sponsor ID
- MEG / IRB202500103
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential Tremor refractory to at least 2 first line tremor medications | Experimental | Diagnostic Test: MRI and fMRI scans, Diagnostic Test: MEG, Diagnostic Test: Sensor-based motor assessments, Other: Clinical evaluations, Other: Questionnaires and rating scales thatEligible 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. |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >50 years and <85 years
- Refractory to at least 2 first line tremor medications
- Skull Density Ratio (SDR) > = 0.35
Key exclusion criteria (4 listed)
- MR/MEG incompatible implants and implantable devices (ex: pacemaker)
- Head tremor interfering with MEG recording
- Severe depression and/or anxiety
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and fMRI scansfunctional MRI, diffusion tensor imaging, anatomical MRI | Diagnostic test | Essential Tremor refractory to at least 2 first line tremor medications |
| MEGnon-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics. | Diagnostic test | Essential Tremor refractory to at least 2 first line tremor medications |
| Sensor-based motor assessmentsresearch-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. | Diagnostic test | Essential Tremor refractory to at least 2 first line tremor medications |
| Clinical evaluationsvital signs, health status review, and neurological exam. | Other | Essential Tremor refractory to at least 2 first line tremor medications |
| Questionnaires and rating scales thatdaily functioning, mood, memory, and tremor | Other | Essential Tremor refractory to at least 2 first line tremor medications |
Primary outcome
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.
21 secondary outcomes
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
Correlation between lesion volume and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between patient age and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between disease duration and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in CRST score and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in tremor amplitude and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in tremor frequency and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in gait speed and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Correlation between change from baseline in postural sway and MEG connectivity
Time frame: Baseline (pre-treatment) to 6 months post-treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Hilliard, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and fMRI scans, MEG and Sensor-based motor assessments in people with Essential Tremor, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerstin Rodriguez, CCMA, CPT (352-273-9000, Kerstin.Rodriguez@neurosurgery.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.