Actively Recruiting
3-D Tractography Focused Ultrasound Ablation for Essential Tremor
Led by University of North Carolina, Chapel Hill · Updated on 2026-01-20
24
Participants Needed
1
Research Sites
N/A
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
Essential tremor (ET) is a common neurological disorder that can cause significant functional and psychological difficulties, often resistant to oral medications. Researchers are investigating a new approach called 3-D tractography Vim-Focused Ultrasound Ablation (Vim-FUSA), which uses advanced brain imaging to better target the area responsible for tremors. This study aims to compare this new method with the standard Vim-FUSA technique and evaluate its safety, feasibility, and effectiveness in both animal and human studies. The treatment involves using focused ultrasound guided by magnetic resonance (MR) imaging and 3-D tractography to precisely ablate 70% of the ventral intermediate nucleus (Vim) in the brain. The procedure includes head preparation, placement of a stereotactic frame, pre-surgery imaging, exploration with low-dose sonications, and therapeutic sonications to deliver the ablation while monitoring tremor and side effects. The study includes an experimental animal phase comparing the new and standard methods and a human phase assessing 24 participants before treatment and three months after. Participants will undergo assessments including videotaped tremor evaluations at baseline and three months post-treatment, with blinded comparison to matched controls. Researchers will use intraoperative MR imaging to distinguish treated tissue from swelling and predict clinical outcomes. Safety, side effects, quality of life related to tremor, and participant satisfaction will also be monitored. Overall participation lasts at least three months, with careful follow-up to evaluate treatment effects and safety.
CONDITIONS
Brief 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 specialists
- 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 (MRI)
You will not qualify if you...
- Uncontrolled high blood pressure
- Medically unstable coronary artery disease
- Blood clotting problems, use of anticoagulant medications, or inability to temporarily stop blood-thinning drugs
- Tremor disorders other than essential tremor
- Unwilling or unable to have tremor surgery while awake
- Significant movement during imaging that cannot be corrected
- Pregnant at enrollment or before surgery
- Dementia
- History of psychosis
- History of drug or alcohol abuse
- Previous brain surgeries like Vim-FUSA, deep brain stimulation, or gamma knife thalamotomy
- Botulinum toxin injections in tremor areas within 3 months before baseline and until 3 months after treatment
- Skull density ratio below 0.4
- Not eligible for FDA-approved clinical use based on current FDA labeling
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo MR-guided focused ultrasound ablation using 3-D tractography to treat essential tremor. This includes head preparation, imaging, targeting, and therapeutic ablation with intraoperative clinical testing.
1 procedure visit (in-person)
Duration - 3 months
Participants are monitored for safety, side effects, and treatment outcomes with tremor assessments and clinical evaluations up to 3 months after the procedure.
Multiple follow-up visits up to Month 3
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
V
Victoria Scott
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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