Using 3-D imaging to improve ultrasound treatment for essential tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Encora X1 in Daily Life for Essential Tremor

  This real-world study tests how the Encora X1 wrist device affects day-to-day activities for adults with essential tremor over three years.

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• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

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  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Microelectrode-based brain stimulation for Parkinson’s and essential tremor

  This early feasibility test checks a new microelectrode-based brain stimulation method in adults with Parkinson’s disease or essential tremor who are already getting deep brain stimulation implants.

  Recruiting Lund University · Lund, Skåne County · NCT07820189

• Non-Invasive Nerve Stimulation for Essential Tremor: Long-Term Safety and Effectiveness

  This study tests whether a non-invasive stimulation device called TAPS helps reduce tremor in adults with essential tremor over a long period.

  Recruiting Ruijin Hospital · Shanghai · NCT07774598

• Low Intensity Focused Ultrasound for Essential Tremor in Adults

  This early-stage, open-label study tests whether repeated low-intensity focused ultrasound can safely and briefly modulate tremor in people with essential tremor.

  Recruiting Early Phase 1 University of California, Los Angeles · Los Angeles, California · NCT07599592

• Closed-loop TMS to reduce tremor

  This trial tries phase-locked transcranial magnetic stimulation (TMS) to reduce tremor in people with essential tremor or Parkinson's disease.

  Recruiting University of Oxford · Oxford, Oxfordshire · NCT07574164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.