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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT03953768
Eligibility Criteria:
Inclusion criteria:
1. Undergoing VNS implantation for the first time as a treatment for epilepsy and
2. Documented follow up with a Louisville-based neurologist in the past 1 year. If at the University of Utah or Baylor University documented ability to travel to their corresponding neurologist.
3. Documented ability to travel to Louisville for outpatient medical care. If at the University of Utah or Baylor University documented ability to travel to their facilities.
Exclusion criteria:
1. Previous treatment with VNS (other than the one implanted for this study)
2. Current pregnancy (contraindication to surgery)
3. Active infection
4. History of cancer or treatment with chemotherapy
5. History of autoimmune disease: Patients who received high effect anticholinergic medication within 30 days of enrollment will be excluded, whereas moderate to low effect anticholinergic medication will be discussed with and decided by the PI.
6. If any high effect anticholinergic medication is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.
7. Patients who received high effect corticosteroids within 30 days of enrollment will be excluded, whereas moderate to low effect corticosteroids will be discussed with and decided by the PI.
8. If any high effect corticosteroid is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.
9. Treatment with antiarrhythmic or (heart) rate controlling medication,
10. Pre-existing cardiac arrhythmia or presence of cardiac pacemaker / defibrillator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
60 Years
Study:
NCT03953768
Study Brief:
Protocol Section:
NCT03953768