Vagal nerve stimulation for autoimmune and gastrointestinal conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of vagal nerve stimulation (VNS) on the immune and gastrointestinal systems in patients undergoing VNS implantation for epilepsy. The research aims to characterize the oral and gut microbiome before and after the procedure, providing insights into the peripheral mechanisms of VNS therapy. By identifying biomarkers of VNS efficacy, the study seeks to lay the groundwork for future research into new disease indications related to gut microbiome and immune modulation. The study involves outpatient surgical implantation of an impulse generator connected to the vagus nerve.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Primary Children's Hospital/University of Utah
  Salt Lake City, Utah, United States Recruiting
• Norton Healthcare
  Louisville, Kentucky, United States Not yet recruiting
• Texas Children's Hospital
  Houston, Texas, United States Active not recruiting

Study contacts

• Study coordinator: Ian S Mutchnick, MD
• Email: ianmutchnick@gmail.com
• Phone: 5026295512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.