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Procedure

Focused Ultrasound Ablation for Essential Tremor

N/A
Recruiting
Led By Vibhor Krishna, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve a treatment called Vim-FUSA using a technique called 3-D tractography to visualize nerve tracts in the brain. The researchers believe that using 3-D tractography will

Who is the study for?
This trial is for individuals with essential tremor, a condition causing involuntary shaking. Participants should be those who haven't responded well to standard treatments. The study excludes people if they have contraindications for magnetic resonance imaging (MRI) or are unable to give informed consent.
What is being tested?
The trial tests an advanced procedure called Vim-FUSA, which uses focused ultrasound ablation guided by 3-D tractography—a technique that maps nerve pathways in the brain—to treat essential tremor. It aims to improve outcomes over standard treatment and includes intraoperative MRI monitoring.
What are the potential side effects?
Potential side effects may include discomfort at the target site, headache, nausea, or other symptoms related to brain procedures. There might also be risks associated with MRI exposure such as warmth in the area being imaged.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change in Tremor
Number of Participants without Side Effects
Relative Change in Tremor
Secondary study objectives
Number of Participants Who Are Satisfied with Treatment
Number of Participants with Procedure-Related Side Effects
Relative Change in Tremor-Related Quality of Life
Other study objectives
Change in Gait Based on Video Assessment
Change in Tremor Based on Video Assessment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 3-D Tractography Vim FUSAExperimental Treatment1 Intervention
Twenty-four consecutive essential tremor (ET) participants undergoing Vim FUSA using 3-D tractography will be assessed at baseline and Month 3.

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,599 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,561 Previous Clinical Trials
4,299,949 Total Patients Enrolled
1 Trials studying Essential Tremor
16 Patients Enrolled for Essential Tremor
Texas Tech University Health Sciences Center, El PasoOTHER
49 Previous Clinical Trials
5,058 Total Patients Enrolled
~16 spots leftby Feb 2028
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