3-D Tractography FUS Ablation for Essential Tremor

Description

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

Essential Tremor

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Study Overview

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Study Details

Study overview

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.

3-D Tractography Focused Ultrasound Ablation for Essential Tremor

3-D Tractography FUS Ablation for Essential Tremor

Condition
Essential Tremor
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians
  • * Symptoms refractory to at least two medications
  • * Stable 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.
  • * Uncontrolled hypertension
  • * Medically unstable coronary artery disease
  • * Coagulopathy, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication
  • * Tremor disorders other than ET
  • * Unwilling or unable to undergo tremor surgery while awake
  • * Significant and non-correctible motion artifact in imaging
  • * Pregnant at the time of enrollment or preoperative evaluation
  • * Dementia
  • * History of psychosis
  • * History of drug or alcohol abuse
  • * Prior brain surgery such as Vim-FUSA, deep brain stimulation, and gamma knife thalamotomy
  • * Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
  • * Skull density ratio lower than 0.4
  • * Does not qualify for FDA-approved clinical use based on current FDA labeling
  • * Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Vibhor Krishna, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina at Chapel Hll

Study Record Dates

2028-02-28