Status:
RECRUITING
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborating Sponsors:
Azienda ULSS 3 Serenissima
IRCCS Centro Neurolesi Bonino Pulejo
Conditions:
Limb Dystonia
Idiopathic Dystonia
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Detailed Description
The FUTURE study is a prospective, randomized, double-blind, sham-controlled, multicenter national clinical trial aimed at assessing the efficacy and safety of unilateral MR-guided focused ultrasound ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07168850
Start Date
January 27 2025
End Date
February 28 2027
Last Update
September 11 2025
Active Locations (4)
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1
Azienda ULSS3 Serenissima
Mestre, (Venice), Italy, 30174
2
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy, 98124
3
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
4
Azienda Ospedaliera Ospedali Riuniti Villa Sofia
Palermo, Italy, 90146