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Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia

NCT07168850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Limb Dystonia
  • Idiopathic Dystonia
  • Medication-refractory Dystonia
  • Dystonia, Focal

Interventions

DEVICE

Exablate MR-guided Focused Ultrasound Pallidotomy

Active Pallidotomy

DEVICE

Sham Sham Exablate MRgFUS Pallidotomy

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

Sponsors & Collaborators

  • Azienda ULSS 3 Serenissima

    collaborator OTHER

  • IRCCS Centro Neurolesi Bonino Pulejo

    collaborator OTHER

  • Azienda Ospedaliera Villa Sofia

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168850 on ClinicalTrials.gov