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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT01486056
Eligibility Criteria:
Inclusion Criteria:
1. At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.
2. Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.
Exclusion Criteria:
1. History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.
2. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
3. History of physical adverse reaction to adhesive electrodes.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01486056
Study Brief:
Protocol Section:
NCT01486056