VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems

Launched by UNIVERSITY OF LOUISVILLE · May 14, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how vagal nerve stimulation (VNS) can affect patients with epilepsy, and whether it also has an impact on other body systems, including the immune system and gut health. VNS involves a small device being placed in the neck that sends electrical signals to the vagus nerve, which may help with controlling seizures. The main goal of the study is to understand how patients’ bowel habits and gut bacteria change before and after the VNS procedure.

To participate in this trial, you need to be getting VNS treatment for epilepsy for the first time and have seen a neurologist in the past year. Unfortunately, if you have had VNS before, are currently pregnant, or have certain medical conditions like a history of cancer or specific heart issues, you won't be eligible. If you join the study, you can expect to have some check-ups before and after the surgery to monitor changes in your health, including how your body responds to the treatment and any changes in your gut health. This trial aims to gather more information on how VNS might help not just with seizures, but also with other bodily functions.

Gender

ALL

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