Essential Tremor Clinical Trials

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3-D Tractography Focused Ultrasound Ablation for Essential Tremor

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Vibhor Krishna, MD
vibhor_krishna@med.unc.edu
+1(919)-445-2410
Backup
Victoria Scott
Victoria_Scott@med.unc.edu
919-966-0864
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 24
Treatments
Experimental: 3-D Tractography Vim FUSA
Twenty-four consecutive essential tremor (ET) participants undergoing Vim FUSA using 3-D tractography will be assessed at baseline and Month 3.
Sponsors
Collaborators: University of Missouri-Columbia, University of Pittsburgh, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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