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Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia

RecruitingNAAges 18 Years - 80 YearsAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07168850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-80 years * Able and willing to consent and attend visits * Idiopathic or hereditary limb dystonia (focal, segmental, or multifocal; isolated or combined) * Refractory to oral therapy and botulinum toxin * Stable medication for ≥30 days and ≥90 days since last BoNT * Capable of communicating during Exablate procedure Exclusion Criteria: * Acquired secondary dystonia * Dementia or other neurodegenerative disorders * Any clinically significant or unstable medical condition, which, in the opinion of the principal investigator or the clinician delegated by the principal investigator, may put the participant at risk when participating in the study (e.g., unstable heart disease or coagulopathy; uncontrolled psychiatric comorbidity) * Prior deep brain stimulation or other brain surgery * Any contraindication to MRI * Skull Density Ratio (SDR) \< 0.40 * Significant brain lesions (eg brain tumor, significant white matter lesions or globus pallidus interna lesions on baseline MRI) * Pregnancy
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What it tests

  • Exablate MR-guided Focused Ultrasound Pallidotomy
  • Sham Sham Exablate MRgFUS Pallidotomy
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Where

4 sites
Azienda ULSS3 Serenissima
Mestre, Italy
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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