MEG to track brain changes after focused ultrasound for essential tremor
Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study
NA · University of Florida · NCT07446192
This project uses MEG and MRI to see how high‑intensity focused ultrasound (HiFU) changes brain activity in people aged 50–84 with essential tremor who haven't responded to at least two medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years to 84 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07446192 on ClinicalTrials.gov |
What this trial studies
This interventional pilot follows participants for about eight months with six in-person visits, including a screening, a pre-treatment assessment, and post-treatment follow-ups at 1 day, 6 weeks, and 6 months. Participants receive HiFU treatment for tremor and undergo non-invasive brain imaging with magnetoencephalography (MEG) and functional MRI (fMRI), along with sensor-based motor assessments and self-report questionnaires. The study compares brain network activity and motor function before and after treatment to identify how HiFU alters neural circuits linked to tremor. Data are collected at a single site (UF Health, Gainesville) using standardized imaging and motor testing protocols.
Who should consider this trial
Good fit: Ideal candidates are people aged 50–84 with essential tremor not controlled by at least two first-line tremor medications and with a skull density ratio (SDR) ≥ 0.35 who can undergo MRI/MEG and travel to UF Health in Gainesville.
Not a fit: People with MR/MEG‑incompatible implants, severe depression or anxiety, severe cognitive impairment, or head tremor that prevents usable MEG recordings are unlikely to benefit from participation or will be excluded.
Why it matters
Potential benefit: If successful, this work could clarify how HiFU reduces tremor and help clinicians better target treatment or select patients likely to benefit.
How similar studies have performed: Previous MR‑guided focused ultrasound (HiFU/MRgFUS) studies have shown meaningful tremor reduction and some imaging work has detected network changes, but using MEG longitudinally in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- UF Health — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Justin Hilliard, MD — University of Florida
- Study coordinator: subeikshanan venkatesan, MBBS
- Email: subeikshanan.venkatesan@neurology.ufl.edu
- Phone: 352-273-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Essential Tremor