Condition: Limb Dystonia · Idiopathic Dystonia · Medication-refractory Dystonia · Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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.
This description comes directly from the study's public registry record.
Roberto Eleopra · +390223942552 · roberto.eleopra@istituto-besta.it
Giovanna Zorzi · +390223942712 · giovanna.zorzi@istituto-besta.it
Always discuss trial participation with your own doctor first.
| Azienda ULSS3 Serenissima | Mestre, (Venice), Italy | Recruiting |
| IRCCS Centro Neurolesi "Bonino-Pulejo" | Messina, Italy | Recruiting |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan, Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia | Palermo, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07168850