Actively Recruiting
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
Led by University of Maryland, Baltimore · Updated on 2026-02-27
10
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
F
Focused Ultrasound Foundation
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of moderate to severe task-specific focal hand dystonia impacting daily or occupational function
- Failed or unsatisfactory response to first treatments like Botulinum toxin or DBS, or refusal of these options
- Age greater than 21 and less than 75 years
- Able and willing to give consent and attend all study visits
- Symptoms present for more than 6 months
- Pallidotomy feasible based on imaging evaluation
- Able to communicate sensations during ExAblate TcMRgFUS treatment
- Inclusion and exclusion criteria agreed upon by two medical team members
You will not qualify if you...
- Contraindications to MRI such as severe claustrophobia or incompatible metal implants
- Presence of generalized dystonia or involvement of two or more adjacent body regions
- Severe psychiatric disorders including uncontrolled depression, anxiety, bipolar disorder, recent suicide attempt or ideation
- Life expectancy less than 12 months
- Use of anticoagulant or antiplatelet medications or underlying blood clotting disorders
- Pregnant women or sexually active women of childbearing age not using contraception
- Unable to provide informed consent due to cognitive impairment or aphasia
- Presence of intracranial mass or acute brain abnormality
- Unstable cardiac conditions or recent heart attack within 6 months
- Substance or alcohol abuse as defined by DSM-IV
- Severe hypertension despite medication
- History of brain hemorrhage, traumatic brain injury, or thalamic stroke
- Recent or multiple strokes
- Life-threatening systemic diseases such as HIV, liver failure, or blood disorders
- Seizure history within the past year
- Unable or unwilling to lie still in a supine position for up to 4 hours during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
D
Dheeraj Gandhi, MD
CONTACT
N
Najme Hosseini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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