Using MRI-guided focused ultrasound to treat hand dystonia

Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

This study is testing a new ultrasound treatment to see if it can help people with hand dystonia who haven't found relief from other therapies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06367608 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for patients suffering from task-specific focal hand dystonia (TSFD), a condition that causes involuntary muscle contractions during specific hand movements. The trial focuses on individuals who have not responded well to other treatments, such as botulinum toxin or deep brain stimulation. Participants will undergo the ExAblate Transcranial treatment, which aims to alleviate symptoms and improve daily functioning. The study will assess the impact of this innovative approach on the quality of life for those affected by TSFD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 75 with moderate to severe TSFD who have not responded to previous treatments.

Not a fit: Patients with generalized dystonia or those who have contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hand function and quality of life for patients with task-specific focal hand dystonia.

How similar studies have performed: While surgical treatments for TSFD are less commonly explored, previous studies on focused ultrasound for other conditions have shown promising results.

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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Where this trial is running

Baltimore, Maryland

• University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Dheeraj Gandhi, MD

Conditions Task-Specific Focal Dystonia