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Procedure
3-D Tractography Vim FUSA 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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Change in Tremor
Number of Participants without Side Effects
Relative Change in Tremor
Secondary outcome measures
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 outcome measures
Change in Gait Based on Video Assessment
Change in Tremor Based on Video Assessment
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
1,723 Previous Clinical Trials
16,342,932 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,018 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
5,096 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants involved in this clinical investigation?
"Indeed, the details on clinicaltrials.gov specify that this particular trial is currently in the recruitment phase. Originally posted on February 28th, 2024, it was last modified on March 19th of the same year. The study aims to enroll a total of 24 individuals at one designated research site."
Answered by AI
Are individuals still being accepted for participation in this ongoing medical study?
"As per the details on clinicaltrials.gov, this ongoing medical investigation is actively seeking participants. Initially shared on February 28th, 2024, the latest update was made on March 19th of the same year."
Answered by AI
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