RecruitingNot ApplicableNCT07168850

Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia

Focused Ultrasound Pallidotomy for Medication-Refractory Limb Dystonia (FUTURE Study)


Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Enrollment

34 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEExablate MR-guided Focused Ultrasound Pallidotomy

Active Pallidotomy

DEVICESham Sham Exablate MRgFUS Pallidotomy

Sham procedure. Identical setup without thermal lesioning. Participants cross over to Active Pallidotomy after 3 months.


Locations(4)

Azienda ULSS3 Serenissima

Mestre, (Venice), Italy

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia

Palermo, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07168850


Related Trials