Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT07168850
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07168850
Study Brief:
Protocol Section:
NCT07168850