Your session is about to expire
← Back to Search
Procedure
MRgFUS for Writer's Cramp (FUS Dystonia Trial)
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
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 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if MRI-guided focused ultrasound (MRgFUS) is a safe and effective treatment for task-specific focal hand dystonias (TSFD), a condition that causes involuntary
Who is the study for?
This trial is for individuals with task specific focal hand dystonias (TSFD), which causes involuntary movements or cramping of the hands during activities like writing or playing instruments. Participants must meet certain health criteria to be eligible.
What is being tested?
The study is testing the safety and effectiveness of a non-invasive procedure called MRgFUS Pallidotomy, which uses MRI-guided focused ultrasound to target brain areas involved in TSFD.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, headache, nausea, dizziness, or other symptoms related to changes in brain activity post-treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment related adverse events
Secondary study objectives
Change in dystonia intensity
Change in patient's perception of quality of life
Change in patient's perception of the effect of the procedure
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: ExAblate Transcranial treatmentExperimental Treatment1 Intervention
The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called globus pallidus internus(GPi). Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.
Find a Location
Who is running the clinical trial?
Focused Ultrasound FoundationOTHER
17 Previous Clinical Trials
450 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,104 Total Patients Enrolled
InSightecIndustry Sponsor
91 Previous Clinical Trials
3,788 Total Patients Enrolled