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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT03742661
Eligibility Criteria:
Inclusion Criteria:
1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
2. Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
3. Male or Female between the ages 22 to 99.
4. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
5. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject or Primary Caregiver must be competent to follow all study procedures.
7. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period of time (up to 120 days), for a minimum of 30 hours/ week.
Exclusion Criteria:
1. The subject cannot be pregnant, or nursing.
2. The subject cannot be sensitive or allergic to adhesives or tapes.
3. The subject may not be enrolled in another Clinical Trial.
4. The subject is homeless or in a home without a power supply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03742661
Study Brief:
Protocol Section:
NCT03742661