Vagal nerve stimulation for autoimmune and gastrointestinal conditions
Prospective Non-randomized Single-arm Trial of Efferent Neuromodulation Immune and Gastrointestinal Systems by VNS in the Epilepsy Population
NA · University of Louisville · NCT03953768
This study is testing if vagal nerve stimulation can improve immune and gut health in patients getting the treatment for epilepsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 0 Years to 60 Years |
| Sex | All |
| Sponsor | University of Louisville (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Louisville, Kentucky and 3 other locations) |
| Trial ID | NCT03953768 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing their first VNS implantation for epilepsy and who can travel to Louisville for follow-up care.
Not a fit: Patients with a history of autoimmune disease or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with autoimmune diseases and gastrointestinal disorders.
How similar studies have performed: While VNS has been FDA approved for epilepsy, the exploration of its effects on the immune and gastrointestinal systems is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky and 3 other locations
- Norton Healthcare — Louisville, Kentucky, United States (NOT_YET_RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (RECRUITING)
- Texas Children's Hospital — Houston, Texas, United States (ACTIVE_NOT_RECRUITING)
- Primary Children's Hospital/University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Ian S Mutchnick, MD
- Email: ianmutchnick@gmail.com
- Phone: 5026295512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autoimmune Diseases, Epilepsy, Autonomic Dysfunction, Inflammatory Bowel Diseases, epilepsy, vagal, autoimmune, autonomic