MRgFUS for Writer's Cramp
(FUS Dystonia Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant or antiplatelet medications.
What data supports the effectiveness of the treatment MRgFUS Pallidotomy for Writer's Cramp?
Is MR-guided focused ultrasound (MRgFUS) generally safe for humans?
MR-guided focused ultrasound (MRgFUS) has been used in treatments for conditions like Parkinson's disease and essential tremor. Some studies report that it is generally safe, but there have been cases of side effects such as skull lesions, functional tremors, and temporary adverse events. More research and long-term follow-up are needed to fully understand its safety.14567
How is MRgFUS Pallidotomy treatment different from other treatments for Writer's Cramp?
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo MR guided focused ultrasound thalamotomy targeting the globus pallidus internus (GPi) using the ExAblate Transcranial system
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including adverse events and changes in dystonia intensity and quality of life
Treatment Details
Interventions
- MRgFUS Pallidotomy
MRgFUS Pallidotomy is already approved in United States, European Union for the following indications:
- Parkinson's disease
- Essential tremor
- Dyskinesias
- Task specific focal hand dystonias (TSFD)
- Parkinson's disease
- Essential tremor
- Dyskinesias
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Focused Ultrasound Foundation
Collaborator
InSightec
Industry Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD