Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Key facts
- Who runs it
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Where
- Messina, Mestre, Milan, and Palermo, ItalySee the 4 sites
- Trial code
- Status
- Recruiting
- People taking part
- 34 people, planned
- Started
- 27 Jan 2025
- Expected to end
- 28 Feb 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Exablate MR-guided Focused Ultrasound Pallidotomy
- Sham Sham Exablate MRgFUS Pallidotomy
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior deep brain stimulation or other brain surgery
- 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)
- Acquired secondary dystonia
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- IRCCS Centro Neurolesi Bonino PulejoMessina, ItalyContact: Silvia MarinoTaking people
- Azienda ULSS3 SerenissimaMestre, ItalyContact: Rocco QuatraleTaking people
- Fondazione IRCCS Istituto Neurologico Carlo BestaMilan, ItalyContact: Roberto EleopraTaking people
- Azienda Ospedaliera Ospedali Riuniti Villa SofiaPalermo, ItalyContact: Marcello C RomanoTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Active Pallidotomy (MRgFUS)Treatment being tested
Patients undergo unilateral pallidotomy using Exablate system under MRI guidance.
Treatment: Exablate MR-guided Focused Ultrasound Pallidotomy
- Sham ProcedureSham treatment, for comparison
Identical setup without thermal lesioning. Participants cross over to active Pallidotomy after 3 months.
Treatment: Exablate MR-guided Focused Ultrasound Pallidotomy and Sham Sham Exablate MRgFUS Pallidotomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Focused Ultrasound Pallidotomy for Medication-Refractory Limb Dystonia (FUTURE Study)
- Fit questions
- Built from NCT07168850, who can take part
- Record updated
- 5 November 2026