3-D Tractography FUS Ablation for Essential Tremor
ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Uncontrolled hypertension
Medically unstable coronary artery disease
Coagulopathy, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication
Tremor disorders other than ET
Trial design
Treatments tested in this trial
- MR-guided Focused Ultrasound Ablation
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Collaborator
University of Pittsburgh
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov