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

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called MRI-guided focused ultrasound (MRgFUS) for people with task-specific focal hand dystonia (TSFD). TSFD is a condition that causes involuntary movements or cramping in the hands during specific tasks, like writing or playing an instrument. The goal of the study is to see if this treatment can help reduce these symptoms and improve daily activities.

To participate in this trial, individuals need to be between 21 and 75 years old and have been diagnosed with moderate to severe TSFD that affects their daily life. They should have tried other treatments, like injections or deep brain stimulation, without satisfactory results or may choose not to pursue those options. Participants will need to attend several study visits and will be asked to communicate their sensations during the MRgFUS treatment, which can take several hours. It’s important to know that certain health conditions, such as severe anxiety or heart problems, may prevent someone from taking part in the study.

Gender

ALL

Eligibility criteria

• 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 sensations during the ExAblate TcMRgFUS treatment
• • 8. Two members of the medical team have agreed upon inclusion and exclusion criteria
• Exclusion Criteria:
• • 1. Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
• • 2. Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck)
• • 3. Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
• • 4. Life expectancy less than 12 months
• • 5. Anticoagulant or antiplatelet medications as well as underlying coagulopathy
• • 6. Pregnant ladies or women of childbearing age who are sexually active and not using contraception
• • 7. Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
• • 8. Presence of intracranial mass or an acute intracranial abnormality
• • 9. Subjects with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40
• • 10. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV)
• • 11. Severe hypertension (diastolic blood pressure \> 100 on medication or persistently elevated systolic blood pressure\>140 mmHg despite adequate antihypertensive medications)
• • 12. History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
• • 13. Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months)
• • 14. Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
• • 15. Subjects with a history of seizures within the past year
• • 16. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
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