Magnetoencephalography (MEG) Pilot Study

NCT07446192 | Recruiting

• 2 other identifiers: IRB202500103OCR48773
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 7 months

Secondary Outcomes (21)

• Correlation between change in tremor amplitude and change in MEG connectivity

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

• Correlation between change in tremor frequency and change in MEG connectivity

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

• Correlation between change in gait parameters and change in MEG connectivity

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

• Correlation between change in postural sway and change in MEG connectivity

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

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

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

Study Arms (1)

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.

Diagnostic Test: MRI and fMRI scans; Diagnostic Test: MEG; Diagnostic Test: Sensor-based motor assessments; Other: Clinical evaluations; Other: Questionnaires and rating scales that

Interventions

MRI and fMRI scans DIAGNOSTIC_TEST

functional MRI, diffusion tensor imaging, anatomical MRI

Essential Tremor refractory to at least 2 first line tremor medications

MEG DIAGNOSTIC_TEST

non-invasive electrophysiological technology that provides high temporal and spatial resolution to examine large-scale cortical dynamics.

Essential Tremor refractory to at least 2 first line tremor medications

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.

Essential Tremor refractory to at least 2 first line tremor medications

Clinical evaluations OTHER

vital signs, health status review, and neurological exam.

Essential Tremor refractory to at least 2 first line tremor medications

Questionnaires and rating scales that OTHER

daily functioning, mood, memory, and tremor

Essential Tremor refractory to at least 2 first line tremor medications

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years and \<85 years
• Refractory to at least 2 first line tremor medications
• Skull Density Ratio (SDR) \> = 0.35

You may not qualify if:

• MR/MEG incompatible implants and implantable devices (ex: pacemaker)
• Head tremor interfering with MEG recording
• Severe depression and/or anxiety
• Severe cognitive impairment

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Interventions

Magnetic Resonance Imaging; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Justin Hilliard, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

subeikshanan venkatesan, MBBS

CONTACT

352-273-9000; subeikshanan.venkatesan@neurology.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: March 3, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)