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Procedure

ExAblate Transcranial treatment for Writer's Cramp (FUS Dystonia Trial)

N/A

Waitlist Available

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

FUS Dystonia Trial 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.Check my eligibility

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.See study design

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.

FUS Dystonia Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment related adverse events

Secondary outcome measures

Change in dystonia intensity

Change in patient's perception of quality of life

Change in patient's perception of the effect of the procedure

FUS Dystonia 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

689 Previous Clinical Trials

374,676 Total Patients Enrolled

Focused Ultrasound FoundationOTHER

15 Previous Clinical Trials

304 Total Patients Enrolled

InSightecIndustry Sponsor

89 Previous Clinical Trials

3,704 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 85 and above eligible to participate in the recruitment process for this medical study?

"This study is seeking participants who are above 21 years old but under the age of 75."

Answered by AI

Is the enrollment for this research study currently open?

"According to the details provided on clinicaltrials.gov, this particular study is not currently seeking participants. Originally listed on 6/1/2024 and last modified on 4/11/2024, it is temporarily closed for patient recruitment. However, there are numerous other ongoing studies actively enrolling patients—31 in total—at present."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"Individuals eligible for this research study must exhibit symptoms of dystonia affecting the hand muscles and fall within the age range of 21 to 75. The trial aims to recruit approximately 10 suitable candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

2024. "MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06367608.

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