Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
University of Maryland, Baltimore
Summary
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.
Description
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…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function 2. Patients who failed to response or had unsatisfactory response to the first treatment, such as Botulinum toxin treatment or DBS or refuse these alternative options 3. Age greater than 21 and less than 75 years 4. Subjects who are able and willing to give consent and able to attend all study visits, 5. Documented chronic, symptoms for more than 6 months duration 6. Pallidotomy is feasible based on evaluation of imaging studies 7. Patient able to communicate sensati…
Interventions
- DeviceExAblate Transcranial treatment
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.
Location
- University of Maryland Medical CenterBaltimore, Maryland