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.
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 refers to a condition where certain movements or tasks trigger involuntary muscle contractions, particularly during specialized and repetitive activities like writing (known as writer's dystonia), typing (typist's dystonia), playing musical instruments (musician's dystonia), or engaging in sports like golf, table tennis, or juggling. While TSFD affects around 1.2-1.5% of the general population, it's more common among athletes and musicians. Writer's dystonia, for example, typically starts with difficulty writing and hand cramping in the dominant hand, possibly spreading to the arm and shoulder muscles over time. In severe cases, the other hand may also be affected. Similarly, typist's dystonia can lead to finger flexion or extension issues during typing. Musician's dystonia is another form, seen in guitarists, pianists, harpists, or flute players, often emerging during the peak of their careers and significantly impacting musical performance. These dystonias can be career-ending as they impair performance and rarely go into remission, with onset often occurring around the age of forty. Surgical treatments for Task-Specific Focal Dystonia (TSFD) are less often explored than for other dystonias. Thalamotomy, targeting the ventro-oralis (Vo) nucleus, has shown some promise for hand dystonias like writer's cramp or musician's dystonia. Anecdotally, some benefit from deep brain stimulation (DBS) targeting the globus pallidus internus (GPi) has also been shown, but large-scale studies for TSFD are lacking. Another promising approach is MR guided focused ultrasound thalamotomy, a non-invasive procedure that uses real-time imaging to precisely target brain areas. This method has already shown success in treating essential tremors and Parkinson's disease symptoms. Recent studies and anecdotal cases have also demonstrated its potential for treating TSFD, with improvements in symptoms observed in patients with writer's cramp, musician's dystonia, and other related conditions. The Exablate MR Guided Focused Ultrasound Transcranial system is a device designed to overcome the limitations of delivering ultrasound through the intact skull. It uses advanced technology like water-cooling, acoustic correction algorithms, and patient-specific CT data to ensure precise and safe delivery of ultrasound energy to targeted brain areas. This pilot study protocol aims to utilize MR guided focused ultrasound thalamotomy as a treatment option for TSFD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's dystonia . 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.
University of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGIncidence of Treatment related adverse events
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
Time frame: All events will be reported up to 6 months from treatment
Change in dystonia intensity
Efficacy of ExAblate TcMRgFUS for pallidotomy will be evaluated using Arm disability dystonia scale (ADDS) and scales specific to writer's cramp (WCRS) or musician's dystonia (TMDS) scores.
Time frame: 6 Months
Change in patient's perception of quality of life
Quality of life assessments will be performed with short form (SF)-36 survey
Time frame: 6 months
Change in patient's perception of the effect of the procedure
Patient Global impression of change (PGIC): The effect of the procedure on patient perceived impact of pain related symptoms, emotions and quality of life will be measured using PGIC scale.
Time frame: 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.