Brain nerve pathway imaging to guide focused ultrasound treatment for essential tremor
Tests nerve pathway imaging to guide ultrasound treatment in people with essential tremor.
Key facts
- Who runs it
- University of North Carolina, Chapel Hill
- Where
- Chapel Hill, United StatesSee the site
- Trial code
- Registry title
- 3-D Tractography FUS Ablation for Essential Tremor
- Status
- Recruiting
- People taking part
- 24 people, planned
- Started
- 28 Feb 2024
- Expected to end
- 28 Feb 2028
- Type of study
- Interventional
- Treatments tested
- MR-guided Focused Ultrasound Ablation
- Record updated
- 8 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe essential tremor that has not improved with medicines. Participants get focused ultrasound treatment of a small brain area, planned with 3-D brain imaging of nerve pathways.
- Age
- 22 Years and older
- Sex
- All sexes
- Disease stage
- Moderate to severe essential tremor, confirmed by at least two doctors trained in movement disorders.
- Earlier treatment
- Tremor did not improve with at least two medications. Tremor medicines must be stable for at least 4 weeks before screening. No prior brain surgery that could affect the procedure, including deep brain stimulation. No botulinum toxin injection in the tremor areas in the three months before the baseline check, and none until 3 months after the procedure.
Main reasons for not taking part
- Tremor disorders other than essential tremor, such as Parkinson disease
- Uncontrolled high blood pressure or unstable heart artery disease
- Blood clotting problems when blood-thinning medicines cannot be stopped for a while
- Dementia, history of psychosis, or pregnancy
- Unable or unwilling to have MR scans or tremor surgery while awake; non-English speaking
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians
- Symptoms refractory to at least two medications
- Stable essential tremor medication regimen for at least 4 weeks prior to screening
- Willing and able to participate in all follow-up visits
- Willing and able to undergo MR imaging
Who cannot take part
- Coagulopathy with inability to temporarily stop any antithrombotic medication
- Unwilling or unable to undergo tremor surgery while awake
- Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation
- Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
- Uncontrolled hypertension
- Medically unstable coronary artery disease
- Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)
- Dementia
- History of psychosis
- Significant and non-correctible motion artifact in imaging
- Pregnant at the time of enrollment or preoperative evaluation
- does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study
- Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation
- non-English speaking
Where in United States
- University of North Carolina at Chapel HillChapel Hill, United StatesContact: Victoria ScottTaking people
About the trial
What the trial wants to find out
The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes.
The group in the trial
- 3-D Tractography Vim FUSATreatment being tested
Twenty-four consecutive essential tremor (ET) participants undergoing Vim FUSA using 3-D tractography will be assessed at baseline and Month 3.
Treatment: MR-guided Focused Ultrasound Ablation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 3-D Tractography Focused Ultrasound Ablation for Essential Tremor
- Plain-language title
- Brain nerve pathway imaging to guide focused ultrasound treatment for essential tremorGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 8 September 2026