RecruitingNot Applicable

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

United States10 participantsStarted 2024-06-10

Plain-language 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.

Who can participate

Age range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment related adverse events

Timeframe: All events will be reported up to 6 months from treatment

Trial details

NCT IDNCT06367608

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Dheeraj Gandhi, MD

(248)-497-8856 dgandhi@umm.edu

View on ClinicalTrials.gov More Task-Specific Focal Dystonia trials

Plain-language summary

Who can participate

Age range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria