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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00773604
Eligibility Criteria:
Inclusion Criteria:
* Refractory primary dystonia diagnosed by a movement disorders neurologist
* Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
* Age 7-80 years (UCSF patients) and 18-80 (VA patients)
Exclusion Criteria:
* Patients considered at high risk for elective neurosurgery because of co-morbid conditions
* Brain MRI showing extensive brain atrophy or small vessel ischemic disease
* Pregnancy
* Inability to tolerate awake microelectrode-guided neurosurgery
* Inability to follow up with post-operative study visits
* Inability to speak or read English
* Patients with a score of 4.5 or lower on the BFMDRS movement scale
* Patients with Secondary dystonia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
80 Years
Study:
NCT00773604
Study Brief:
Protocol Section:
NCT00773604