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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Centro Neurolesi Bonino-Pulejo
RECRUITING
Messina
Azienda ULSS3 Serenissima
RECRUITING
Mestre
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Azienda Ospedaliera Ospedali Riuniti Villa Sofia
RECRUITING
Palermo
Contact Information
Primary
Roberto Eleopra
roberto.eleopra@istituto-besta.it
+390223942552
Backup
Giovanna Zorzi
giovanna.zorzi@istituto-besta.it
+390223942712
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 34
Treatments
Experimental: Active Pallidotomy (MRgFUS)
Patients undergo unilateral pallidotomy using Exablate system under MRI guidance.
Sham_comparator: Sham Procedure
Identical setup without thermal lesioning. Participants cross over to active Pallidotomy after 3 months.
Sponsors
Collaborators: Azienda Ospedaliera Villa Sofia, IRCCS Centro Neurolesi Bonino Pulejo, Azienda ULSS 3 Serenissima
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov