Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07168850

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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