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:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT04650958
Eligibility Criteria:
Inclusion Criteria:
1. Patients must meet criteria for the diagnosis of isolated generalized or segmental dystonia, including idiopathic and inherited dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
2. Patients will be ≥ 14 years old;
3. The course of disease will be ≥ 3 years;
4. Patients will have:
1. Significant dystonia symptoms;
2. Compromised life quality;
3. Unsatisfactory response to oral treatment with anticholinergic agents antiepileptic agents, anti-dopamine agents, dopaminergic agents, or muscle relaxants;
4. Unsatisfactory response to or contraindication for previous botulinum toxin treatment; and
5. Ability to provide written informed consent.
Exclusion Criteria:
1. Patients with a diagnosis or probable diagnosis of acquired, compound, and complex dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
2. Previous brain surgery for dystonia;
3. Patients with cognitive impairment (MMSE score \<24) or moderate-severe depressive disorder (BDI\>25);
4. Patients with marked brain atrophy identified by magnetic resonance imaging (MRI) or computed tomography (CT);
5. Patients with other medical or psychiatric comorbidities that could increase the surgical risk or interfere with completion of the trial;
6. Patients with increased bleeding risk, or other factors contraindicating neurosurgery or general anesthesia;
7. Patients unable to cooperate with the assessments during the follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT04650958
Study Brief:
Protocol Section:
NCT04650958