Task-Specific Focal DystoniaFUS DystoniaNCT06367608
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
A study testing ExAblate Transcranial treatment in people with Task-Specific Focal Dystonia, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Task-Specific Focal Dystonia
- What is being tested?
- ExAblate Transcranial treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Najme Hosseini, 410-328-4068, NHosseini@som.umaryland.edu
Kaitlyn Henry, MS, 410-328-0939, khenry@som.umaryland.edu
About this study
Official title: Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
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.
Read the detailed 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 refers to a condition where certain movements or tasks trigger involuntary muscle contractions, particularly during specialized and repetitive activities like writing (known as writer's dystonia), typing (typist's dystonia), playing musical instruments (musician's dystonia), or engaging in sports like golf, table tennis, or juggling. While TSFD affects around 1.2-1.5% of the general population, it's more common among athletes and musicians. Writer's dystonia, for example, typically starts with difficulty writing and hand cramping in the dominant hand, possibly spreading to the arm and shoulder muscles over time. In severe cases, the other hand may also be affected. Similarly, typist's dystonia can lead to finger flexion or extension issues during typing. Musician's dystonia is another form, seen in guitarists, pianists, harpists, or flute players, often emerging during the peak of their careers and significantly impacting musical performance. These dystonias can be career-ending as they impair performance and rarely go into remission, with onset often occurring around the age of forty.
Surgical treatments for Task-Specific Focal Dystonia (TSFD) are less often explored than for other dystonias. Thalamotomy, targeting the ventro-oralis (Vo) nucleus, has shown some promise for hand dystonias like writer's cramp or musician's dystonia. Anecdotally, some benefit from deep brain stimulation (DBS) targeting the globus pallidus internus (GPi) has also been shown, but large-scale studies for TSFD are lacking.
Another promising approach is MR guided focused ultrasound thalamotomy, a non-invasive procedure that uses real-time imaging to precisely target brain areas. This method has already shown success in treating essential tremors and Parkinson's disease symptoms. Recent studies and anecdotal cases have also demonstrated its potential for treating TSFD, with improvements in symptoms observed in patients with writer's cramp, musician's dystonia, and other related conditions.
The Exablate MR Guided Focused Ultrasound Transcranial system is a device designed to overcome the limitations of delivering ultrasound through the intact skull. It uses advanced technology like water-cooling, acoustic correction algorithms, and patient-specific CT data to ensure precise and safe delivery of ultrasound energy to targeted brain areas. This pilot study protocol aims to utilize MR guided focused ultrasound thalamotomy as a treatment option for TSFD.
- Conditions
- Task-Specific Focal Dystonia
- Being tested
- ExAblate Transcranial treatment
- Medical subject headings
- Dystonia, Focal, Task-Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Transcranial treatmentDevice
Also called The ExAblate® MR guided focused ultrasound system
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.
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Transcranial treatment | Experimental | The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . 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. Receives: Device: ExAblate Transcranial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment related adverse events
Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.
Measured: All events will be reported up to 6 months from treatment
Secondary outcomes (3)
Change in dystonia intensity
Efficacy of ExAblate TcMRgFUS for pallidotomy will be evaluated using Arm disability dystonia scale (ADDS) and scales specific to writer's cramp (WCRS) or musician's dystonia (TMDS) scores.
Measured: 6 Months
Change in patient's perception of quality of life
Quality of life assessments will be performed with short form (SF)-36 survey
Measured: 6 months
Change in patient's perception of the effect of the procedure
Patient Global impression of change (PGIC): The effect of the procedure on patient perceived impact of pain related symptoms, emotions and quality of life will be measured using PGIC scale.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start10 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Task-Specific Focal DystoniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367608
- Sponsor's protocol ID
- HP-00104695
- Acronym
- FUS Dystonia
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
- ClinicalTrials.gov ID
- NCT06367608
- Acronym / sponsor ID
- FUS Dystonia / HP-00104695
- Conditions
- Task-Specific Focal Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 refers to a condition where certain movements or tasks trigger involuntary muscle contractions, particularly during specialized and repetitive activities like writing (known as writer's dystonia), typing (typist's dystonia), playing musical instruments (musician's dystonia), or engaging in sports like golf, table tennis, or juggling. While TSFD affects around 1.2-1.5% of the general population, it's more common among athletes and musicians. Writer's dystonia, for example, typically starts with difficulty writing and hand cramping in the dominant hand, possibly spreading to the arm and shoulder muscles over time. In severe cases, the other hand may also be affected. Similarly, typist's dystonia can lead to finger flexion or extension issues during typing. Musician's dystonia is another form, seen in guitarists, pianists, harpists, or flute players, often emerging during the peak of their careers and significantly impacting musical performance. These dystonias can be career-ending as they impair performance and rarely go into remission, with onset often occurring around the age of forty.
Surgical treatments for Task-Specific Focal Dystonia (TSFD) are less often explored than for other dystonias. Thalamotomy, targeting the ventro-oralis (Vo) nucleus, has shown some promise for hand dystonias like writer's cramp or musician's dystonia. Anecdotally, some benefit from deep brain stimulation (DBS) targeting the globus pallidus internus (GPi) has also been shown, but large-scale studies for TSFD are lacking.
Another promising approach is MR guided focused ultrasound thalamotomy, a non-invasive procedure that uses real-time imaging to precisely target brain areas. This method has already shown success in treating essential tremors and Parkinson's disease symptoms. Recent studies and anecdotal cases have also demonstrated its potential for treating TSFD, with improvements in symptoms observed in patients with writer's cramp, musician's dystonia, and other related conditions.
The Exablate MR Guided Focused Ultrasound Transcranial system is a device designed to overcome the limitations of delivering ultrasound through the intact skull. It uses advanced technology like water-cooling, acoustic correction algorithms, and patient-specific CT data to ensure precise and safe delivery of ultrasound energy to targeted brain areas. This pilot study protocol aims to utilize MR guided focused ultrasound thalamotomy as a treatment option for TSFD.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Transcranial treatment | Experimental | Device: ExAblate Transcranial treatmentThe ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate Transcranial treatmentAlso: The ExAblate® MR guided focused ultrasound systemThe 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. | Device | ExAblate Transcranial treatment |
Primary outcome
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.
3 secondary outcomes
Change in dystonia intensity
Time frame: 6 Months
Change in patient's perception of quality of life
Time frame: 6 months
Change in patient's perception of the effect of the procedure
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Transcranial treatment in people with Task-Specific Focal Dystonia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dheeraj Gandhi, MD ((248)-497-8856, dgandhi@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment related adverse events (time frame: All events will be reported up to 6 months from treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.