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VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
NCT03953768 · View on ClinicalTrials.gov ↗
Study Summary
Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of action is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune and gastrointestinal systems. Concrete characterization of the peripheral effects of VNS in human gut microbiome and immune systems will: (1) elucidate peripheral mechanism of action of chronic VNS therapy, (2) identify peripheral preoperative biomarker of VNS efficacy, and (3) create a foundation for research investigating new GM and IM-related disease indications for VNS. The primary objective of this study is to characterize the pre- and post-operative oral and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre-operative and post-operative immune profile of patients undergoing VNS implantation for epilepsy, (2) to elucidate whether oral and/or gut microbiota changes are related to VNS efficacy for epilepsy and (3) identification of a biomarker predicting VNS efficacy.
Conditions Studied
Interventions
- DEVICE Vagal nerve stimulation (VNS)
Study Locations (4)
Kentucky
- Norton Healthcare — Louisville
- University of Louisville — Louisville
Texas
- Texas Children's Hospital — Houston
Utah
- Primary Children's Hospital/University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03953768
The ClinicalTrials.gov registry entry for NCT03953768 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 260 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention — of which Vagal nerve stimulation (VNS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03953768 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Kentucky, Texas, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03953768 about?
NCT03953768 is a clinical study titled "VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems". Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of action is...
What is the current status of trial NCT03953768?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2021-04-01. Estimated completion is 2026-12-31.
What conditions does trial NCT03953768 study?
This clinical trial studies the following conditions: Epilepsy, Inflammatory Bowel Diseases, Autoimmune Diseases, Autonomic Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03953768?
The interventions under investigation include: Vagal nerve stimulation (VNS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03953768?
This trial is sponsored by University of Louisville, which has 260 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03953768 being conducted?
This trial has 4 study locations across Kentucky, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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