🔎 Trials Near Me

Home › Essential Tremor › NCT06331052

3-D Tractography FUS Ablation for Essential Tremor

Recruiting

3-D Tractography Focused Ultrasound Ablation for Essential Tremor

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
Inclusion 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 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.

Exclusion Criteria:

* Uncontrolled hypertension
* Medically unstable coronary artery disease
* Coagulopathy with inability to temporarily stop any antithrombotic medication
* Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)
* 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
* Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation
* Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
* does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study
* Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.
* non-English speaking

About the study

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.

What is being tested

Sponsor: University of North Carolina, Chapel Hill · Participants: 24 · Started: Feb 28, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06331052

Locations in the U.S.

North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.