NCT06367608 · University of Maryland, Baltimore
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
(FUS Dystonia)
What this study is about
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.
View original scientific 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 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.
Interventions
DEVICE
ExAblate 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.
Primary outcome measures
Incidence of Treatment related adverse events
Time frame: All events will be reported up to 6 months from treatment
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Two members of the medical team have agreed upon inclusion and
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
- 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.) \-
Where
- Baltimore, Maryland
Collaborators
Focused Ultrasound Foundation, InSightec
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations