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Sound waves vs. dystonia: could a No-Cut brain treatment end limb twisting?

NCT ID NCT07168850

Disease control Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a non-invasive procedure called focused ultrasound for adults with limb dystonia that hasn't improved with medication or Botox. The treatment uses sound waves to create a tiny lesion in a brain area that controls movement. Researchers will compare real treatment to a sham procedure to see if it safely reduces symptoms and improves quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Dystonia dystonic disorder early-onset generalized limb-onset dystonia focal dystonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dystonia, focal Idiopathic dystonia Limb dystonia Medication-refractory dystonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia

    RECRUITING

    Palermo, 90146, Italy

  • Azienda ULSS3 Serenissima

    RECRUITING

    Mestre, (Venice), 30174, Italy

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

    RECRUITING

    Messina, 98124, Italy

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