NCT06331052 3-D Tractography FUS Ablation for Essential Tremor
| NCT ID | NCT06331052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-02-28 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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, 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.
Contact & Investigator
Vibhor Krishna, MD
PRINCIPAL INVESTIGATOR
University of North Carolina at Chapel Hll
Frequently Asked Questions
Who can join the NCT06331052 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06331052 currently recruiting?
Yes, NCT06331052 is actively recruiting participants. Contact the research team at vibhor_krishna@med.unc.edu for enrollment information.
Where is the NCT06331052 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06331052 clinical trial?
NCT06331052 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Vibhor Krishna, MD at University of North Carolina at Chapel Hll. The trial plans to enroll 24 participants.