NCT07168850 Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
| NCT ID | NCT07168850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Limb Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-01-27 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Limb Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168850 currently recruiting?
Yes, NCT07168850 is actively recruiting participants. Contact the research team at roberto.eleopra@istituto-besta.it for enrollment information.
Where is the NCT07168850 trial being conducted?
This trial is being conducted at Mestre, Italy, Messina, Italy, Milan, Italy, Palermo, Italy.
Who is sponsoring the NCT07168850 clinical trial?
NCT07168850 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 34 participants.