MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD) (NCT06367608) | Clinical Trial Compass
RecruitingNot Applicable
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
United States10 participantsStarted 2024-06-10
Plain-language 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function
✓. 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
✓. Age greater than 21 and less than 75 years
✓. Subjects who are able and willing to give consent and able to attend all study visits,
✓. Documented chronic, symptoms for more than 6 months duration
✓. Pallidotomy is feasible based on evaluation of imaging studies
✓. Patient able to communicate sensations during the ExAblate TcMRgFUS treatment
Exclusion criteria
✕. Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
✕. Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck)
✕. Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
✕. Life expectancy less than 12 months
✕. Anticoagulant or antiplatelet medications as well as underlying coagulopathy
What they're measuring
1
Incidence of Treatment related adverse events
Timeframe: All events will be reported up to 6 months from treatment