Actively Recruiting
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-02-11
34
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
A
Azienda ULSS 3 Serenissima
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out if a non-invasive procedure called focused ultrasound can safely and effectively treat limb dystonia in adults who have not improved with medications or botulinum toxin injections. The main questions it aims to answer are: * Does focused ultrasound reduce the severity of limb dystonia symptoms? * Is the procedure safe and well tolerated? Researchers will compare people who receive focused ultrasound treatment to those who receive a sham procedure (a look-alike procedure without active treatment) to see if the treatment works. Focused ultrasound works by producing a very small (millimeter-size) lesion in a deep brain region. In this study, the lesion is located in a region called globus pallidus, which helps control movement. Participants will: * Be randomly assigned to one of two groups: focused ultrasound or sham * Undergo a procedure using MRI and focused ultrasound to target a part of the brain called the globus pallidus * Be followed for 6 months after treatment to assess changes in symptoms, quality of life, and brain function * Participants in the sham group will be offered the real treatment after 3 months This study may offer a new non-surgical treatment option for people with dystonia affecting the arm or leg, whose pharmacological control is unsatisfactory.
CONDITIONS
Official Title
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Able and willing to provide consent and attend all study visits
- Diagnosis of idiopathic or hereditary limb dystonia (focal, segmental, or multifocal; isolated or combined)
- Limb dystonia refractory to oral medications and botulinum toxin treatment
- Stable medication regimen for at least 30 days and at least 90 days since last botulinum toxin injection
- Ability to communicate during the Exablate focused ultrasound procedure
You will not qualify if you...
- Acquired secondary dystonia
- Dementia or other neurodegenerative disorders
- Any clinically significant or unstable medical condition that may pose risk during the study (e.g., unstable heart disease, coagulopathy, uncontrolled psychiatric conditions)
- Previous deep brain stimulation or other brain surgery
- Any contraindication to MRI
- Skull Density Ratio less than 0.40
- Significant brain lesions on baseline MRI (e.g., brain tumor, white matter lesions, globus pallidus interna lesions)
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Azienda ULSS3 Serenissima
Mestre, (Venice), Italy, 30174
Actively Recruiting
2
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy, 98124
Actively Recruiting
3
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
4
Azienda Ospedaliera Ospedali Riuniti Villa Sofia
Palermo, Italy, 90146
Actively Recruiting
Research Team
R
Roberto Eleopra
CONTACT
G
Giovanna Zorzi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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