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 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT07220161
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18 to 65 years of age at time of consent
* Subject must have a confirmed diagnosis of epilepsy of at least 1 year, specified as focal onset epilepsy.
* Focal epilepsy with motor signs
* A minimum seizure frequency of one seizure over a 4-week period
* Subject must have failed to achieve seizure control with at least two appropriate antiseizure medications (ASM) based on the 2009 ILAE definition of drug resistant epilepsy
* Current treatment with at least 1 ASM with stable doses for at least three months
Exclusion Criteria:
* Any condition that would impact a subject's ability to follow study procedures or subject's safety
* History of significant adverse reactions to electrical stimulation (e.g. TEMS device)
* Subjects with only focal aware nonmotor seizures
* Women of childbearing age, pregnant or breastfeeding
* Implanted cardiac pacemaker or implanted/wearable defibrillator or implanted metallic device in head
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07220161
Study Brief:
Protocol Section:
NCT07220161