RecruitingNot ApplicableNCT06331052

3-D Tractography FUS Ablation for Essential Tremor

3-D Tractography Focused Ultrasound Ablation for Essential Tremor

Sponsor

University of North Carolina, Chapel Hill

Enrollment

24 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Essential Tremor

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

Min Age: 22 Years

Inclusion Criteria5

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.

Exclusion Criteria15

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.

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Interventions

DEVICEMR-guided Focused Ultrasound Ablation

3-D tractography Vim-FUSA -D tractography Vim-FUSA will be carried out as follows: (a) head shaving and placement of the stereotactic frame (Integra radionics frame, Integra Lifesciences, NJ, USA) secured to the skull with transcutaneous screws; (b) positioning on the procedure table and placement of the ultrasound transducer; (c) acquisition of conventional magnetic resonance (MR) imaging and co-registration with the CT head and 3-D tractography imaging acquired pre-surgically; (d) exploration of the target area with subtherapeutic sonications; (e) intraoperative monitoring with clinical testing of tremor and side effects with a standardized protocol. (f) Therapeutic sonications in the target area to deliver definitive ablation followed by clinical testing of tremor and side effects with a standardized protocol as described in section (e).