3-D Tractography FUS Ablation for Essential Tremor

This study is testing a new way to perform Focused Ultrasound Ablation (FUSA) for essential tremor (ET). It uses 3-D tractography, a special imaging technique that shows nerve pathways in the brain, to improve the accuracy of the procedure. Researchers believe this advanced method will be safer and more effective than the standard FUSA. You may be able to join if you are at least 22 years old, have moderate to severe ET that hasn't improved with at least two medications, and are able to have MRI scans. The study will measure how much your tremor changes and look for any side effects. The current status of this study is unclear, and it plans to enroll 24 participants.

Study design: This is an interventional study with a planned enrollment of 24 participants. The phase of the study is not specified.
What's involved: Participants will undergo head shaving, placement of a stereotactic frame, and positioning for the procedure. You will also need to participate in follow-up visits and undergo MR imaging.
Compensation: Not stated in the trial record.
Follow-up: Tremor changes will be measured at Baseline and Month 3 after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

3-D Tractography FUS Ablation for Essential Tremor

Recruiting

NAAges 22+InterventionalTreatment

University of North Carolina, Chapel Hill

~24 participants

Updated 2026-01-20 on ClinicalTrials.gov

What's tested:MR-guided Focused Ultrasound Ablation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of Participants without Side Effects

Measured over during the surgical procedure

+2 more outcomes measured

Conditions

Essential Tremor

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

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

Who to contact

Vibhor Krishna, MD

[email protected]

+1(919)-445-2410

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Number of Participants without Side Effectsduring the surgical procedure
Feasibility is defined as the ability to complete the procedure without side effects.
Absolute Change in TremorBaseline, Month 3
The absolute change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate absolute change from baseline and averaged across subjects. High absolute change from baseline is better (shows improvement).
Relative Change in TremorBaseline, Month 3
The relative change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate relative change from baseline and averaged across subjects. High relative change from baseline is better (shows improvement).

Trialytics