Using 3-D imaging to improve ultrasound treatment for essential tremor
3-D Tractography Focused Ultrasound Ablation for Essential Tremor
This study is testing whether using 3-D imaging can make ultrasound treatment for essential tremor more effective for patients who haven't found relief from medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06331052 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the effectiveness of focused ultrasound ablation (FUSA) for treating essential tremor by incorporating 3-D tractography, a neuroimaging technique that visualizes nerve tracts in the brain. The study will evaluate the safety and feasibility of this advanced approach compared to standard FUSA, focusing on improving the accuracy of the ablation process. Intraoperative magnetic resonance imaging will be utilized to monitor the procedure and differentiate between ablated tissue and surrounding edema, potentially leading to better clinical outcomes for patients. The trial is designed for patients whose tremor symptoms have not responded adequately to medication.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with moderate to severe essential tremor who have not found relief from at least two different medications.
Not a fit: Patients with uncontrolled hypertension, significant psychiatric history, or those who have previously undergone certain brain surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients with essential tremor who do not respond to conventional therapies.
How similar studies have performed: While focused ultrasound ablation has been FDA-approved for essential tremor, the integration of 3-D tractography is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Vibhor Krishna, MD — University of North Carolina at Chapel Hll
- Study coordinator: Vibhor Krishna, MD
- Email: vibhor_krishna@med.unc.edu
- Phone: +1(919)-445-2410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.