Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Exablate MR-guided Focused Ultrasound Pallidotomy
  • Sham Sham Exablate MRgFUS Pallidotomy

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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

Lead sponsor

Azienda ULSS 3 Serenissima

Collaborator

IRCCS Centro Neurolesi Bonino Pulejo

Collaborator

Azienda Ospedaliera Villa Sofia

Collaborator