Actively Recruiting
3-D Tractography FUS Ablation for Essential Tremor
Led by University of North Carolina, Chapel Hill · Updated on 2026-01-20
24
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
T
Texas Tech University Health Sciences Center, El Paso
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
3-D Tractography FUS Ablation for Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate to severe essential tremor confirmed by at least two movement disorder trained physicians
- Symptoms not controlled by at least two medications
- Stable medication regimen for at least 4 weeks before screening
- Willing and able to participate in all follow-up visits
- Willing and able to undergo magnetic resonance imaging
You will not qualify if you...
- Uncontrolled high blood pressure
- Medically unstable coronary artery disease
- Blood clotting disorders, anticoagulant therapy, or inability to stop antithrombotic medication temporarily
- Tremor disorders other than essential tremor
- Unwilling or unable to have tremor surgery while awake
- Significant motion artifacts affecting imaging quality
- Pregnant during enrollment or preoperative evaluation
- Dementia
- History of psychosis
- History of drug or alcohol abuse
- Previous brain surgery such as Vim-FUSA, deep brain stimulation, or gamma knife thalamotomy
- Botulinum toxin injection in tremor-affected areas within three months before baseline and until three months after Vim-FUSA
- Skull density ratio below 0.4
- Does not meet FDA-approved clinical use criteria
- Any significant medical issues that may affect safety or study results as determined by neurologist or neurosurgeon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
V
Vibhor Krishna, MD
CONTACT
V
Victoria Scott
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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