Vagal Nerve Stimulation (VNS) for Autoimmune and Gastrointestinal Conditions
This study is looking at how Vagal Nerve Stimulation (VNS) affects the immune system and gut (gastrointestinal system) in people who are getting VNS for epilepsy. VNS involves implanting a small device that sends electrical pulses to a nerve in your neck. While VNS is approved for epilepsy, researchers want to understand if it also impacts other body systems, like your gut bacteria (metagenomic microbiome profile) and bowel habits. The study aims to enroll 30 participants, aged 0 to 60, who are having VNS implanted for the first time for epilepsy and are already seeing a neurologist in Louisville, or can travel to a neurologist at the University of Utah or Baylor University. Success will be measured by changes in your gut microbiome and bowel habits after one year.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment (VNS implantation). It aims to enroll 30 participants.
- What's involved
- Participants will undergo VNS implantation surgery. The study will measure your gut microbiome and bowel habits at one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after VNS implantation to assess changes in their gut microbiome and bowel habits.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
At a glance
Conditions
Where it's being run
4 sites across 3 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Metagenomic microbiome profile1 year
Stool and saliva specimens will be used to generate metagenomic profiles of gut flora populations. Pre- and post-VNS gut profiles will be compared. It is important to note that the genomic profile of all gut flora is the outcome, rather than the presence or absence of any specific type of bacteria.
- Bowel movement frequency1 year
A brief clinical questionnaire regarding the frequency and consistency of bowel movements will be administered. This will be done pre- and post-VNS implantation in each patient. Any medications to manage diarrhea and constipation will be carefully recorded as well as their efficacy.
- Bowel habits1 year
A clinical bowel habits questionnaire will be administered at each study visit to determine changes in bowel habits pre and post operatively. Additionally, the Bristol stool scale will be assessed at each visit.
- Immune Profile 1 - Flow cytometric profiling of cell populations1 year
One milliliter of whole blood from each subject will be aliquoted into separate tube and directly stained with fluorochrome-conjugated antibodies to investigate the cellular composition of the blood. Subtypes of lymphocytes, monocytes and granulocytes will be defined by set phenotypic marker expression
- Immune Profile 2 - Ex vivo stimulation of cells in whole blood1 year
Up to 10 ml of the whole blood will be cultured in 24-well tissue culture plates in the presence and absence of innate immune cell activators, such as TLR ligands, LPS, CpG ODN, poly I:C or flagellin, or adaptive immune activators such as anti-CD3/anti-CD28 beads, PHA or recall antigens. Culture supernatants and cells will be harvested at the needed time points and analyzed via MSD and qPCR, respectively.
- Inflammatory Profile 1 - Meso Scale Discovery (or MSD) analysis for pro-inflammatory cytokines/chemokines1 year
Serum electrochemiluminescence detection analysis of the following cytokines/chemokines: IFNg, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNFα. Units in Picograms/ml or Nanograms/ml depending on the specific chemokine/cytokine
- Inflammatory Profile 2 - Meso Scale Discovery (or MSD) analysis for metabolic hormones1 year
Serum electrochemiluminescence detection analysis of the following hormones: GLP-1, insulin, Glucagon, Leptin. All in picograms/mL.
- Inflammatory Profile 3 - Metabolomics for Short Chain Fatty acids (SCFAs)1 year
Short Chain Fatty Acids (SCFAs) in both feces and serum will be derivatized, extracted in organic solvent and analyzed using Gas chromatography-mass spectrometry (GC-MS) to determine the levels of short-chain fatty acids. To the microbial community SCFAs are a necessary waste product, required to balance redox equivalent production in the anaerobic environment of the gut. SCFAs are saturated aliphatic organic acids that consist of one to six carbons of which acetate (C2), propionate (C3), and butyrate (C4) are the most abundant (≥95%). Acetate, propionate, and butyrate are present in an approximate molar ratio of 60:20:20 and will be measured in picomoles/mL.
- Inflammatory Profile 4 - Intestinal inflammation and permeability markers1 year
sCD163 (nanograms/mL), sCD14 (micrograms/mL), CRP (mg/L), and I-FABP (picograms/mL) are markers of intestinal inflammation and permeability and will be measured using an enzyme-linked immunosorbent assay (ELISA) performed on cell-free supernatants such as plasma, serum and urine. The units of measurement