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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT05241366
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a diagnosis of PNES, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the ILAE, confirmed by video recording and/or V-EEG monitoring, and who have a monthly seizure frequency greater than 3.
2. Patients who have a record at the institute with the diagnosis of PNES.
3. Patients with an encephalic MRI.
4. Patients who give their written consent to participate in the protocol.
5. Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.
Exclusion Criteria:
1. Patients who cannot answer the scales and other clinimetric instruments.
2. Patients with a history of previous or current epilepsy.
3. Patients with other major neurological comorbidities (tumor, cerebrovascular event (CVE), cranioencephalic trauma (TBI)).
4. Patients currently taking medications that lower the seizure threshold (Bupropion).
5. Patients with psychiatric comorbidities such as psychosis/bipolar disorder/substance abuse.
6. Patients with certain implanted metallic devices (pacemakers).
7. Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05241366
Study Brief:
Protocol Section:
NCT05241366