MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
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
10 participants
Jun 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria17
- 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
- Pregnant ladies or women of childbearing age who are sexually active and not using contraception
- Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
- Presence of intracranial mass or an acute intracranial abnormality
- 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
- 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)
- Severe hypertension (diastolic blood pressure \> 100 on medication or persistently elevated systolic blood pressure\>140 mmHg despite adequate antihypertensive medications)
- History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
- Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months)
- 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.
- Subjects with a history of seizures within the past year
- 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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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06367608