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New treatment option for Limb Dystonia
Official title Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
ClinicalTrials.gov ID: NCT07168850
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Prior deep brain stimulation or other brain surgery
- Any contraindication to MRI
- Skull Density Ratio (SDR) \< 0.40
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mestre, (Venice), Italy
- Messina, Italy
- Milan, Italy
- Palermo, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mestre, (Venice), Italy; Messina, Italy; Milan, Italy; Palermo, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.