Unilateral focused ultrasound pallidotomy for medication‑resistant limb dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FUTURE trial is a prospective, randomized, double‑blind, sham‑controlled, multicenter study comparing unilateral MR‑guided focused ultrasound (MRgFUS) pallidotomy targeting the globus pallidus internus (GPi) to a sham procedure in adults with medication‑refractory limb dystonia. Thirty‑four participants aged 18–80 with idiopathic or genetic focal/segmental limb dystonia who failed oral drugs and botulinum toxin will be randomly assigned to active or sham treatment. The procedure uses MRI guidance and Exablate MRgFUS to create a millimeter‑scale lesion in the GPi while participants are awake and monitored; safety and symptom severity will be tracked over scheduled follow‑up visits. Key exclusions include secondary (acquired) dystonia, prior deep brain stimulation or other brain surgery, MRI contraindications, and low skull density ratio (SDR < 0.40).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Azienda ULSS3 Serenissima
  Mestre, (Venice), Italy Recruiting
• IRCCS Centro Neurolesi "Bonino-Pulejo"
  Messina, Italy Recruiting
• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Italy Recruiting
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia
  Palermo, Italy Recruiting

Study contacts

• Study coordinator: Roberto Eleopra
• Email: roberto.eleopra@istituto-besta.it
• Phone: +390223942552

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using GPi brain signals to guide DBS programming for primary dystonia

  This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.

  Recruiting Newcastle-upon-Tyne Hospitals NHS Trust · Newcastle upon Tyne, Tyne & Wear · NCT07309133

• Investigating the relationship between genetic mutations and brain changes in dystonia

  This study is trying to see how genetic changes linked to dystonia affect the brain in people with the condition compared to healthy individuals.

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• Ultrasound-guided versus landmark-based botulinum toxin injections for cervical dystonia

  This trial will try ultrasound-guided botulinum toxin injections to see if adults with idiopathic cervical dystonia have better quality of life and similar safety compared with injections done using anatomical landmarks.

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• Neuromodulation effects on laryngeal dystonia

  This study is testing if a brain stimulation treatment can help people with laryngeal dystonia improve their voice and overall quality of life.

  Recruiting MGH Institute of Health Professions · Boston, Massachusetts · NCT05095740

• Brain network patterns in focal dystonia

  Researchers will use MRI scans and blood tests to try to find brain and genetic differences in adults with focal dystonia, their unaffected relatives, and healthy volunteers.

  Recruiting Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT03042962

• Using Xeomin to treat focal hand dystonia

  This study is testing if injections of Xeomin can help people with focal hand dystonia feel better compared to a placebo.

  Recruiting Phase 3 Ente Ospedaliero Cantonale, Bellinzona · Bern and 4 other locations · NCT03977493

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.