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NCT03953768 · ClinicalTrials.gov registry record · NA
VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
A NA study of Epilepsy and Inflammatory Bowel Diseases, sponsored by University of Louisville.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT03953768: Recruiting NA study of Epilepsy and Inflammatory Bowel Diseases, sponsored by University of Louisville.
NCT03953768 is a NA study of Epilepsy and Inflammatory Bowel Diseases that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 30 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03953768, a NA study of Epilepsy and Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
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.
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 |
What NCT03953768 shows while recruiting
NCT03953768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
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.
NCT03953768 reports a single indexed study location in Kentucky, Texas, Utah.
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.
What interventions are being tested in trial NCT03953768?
The interventions under investigation include: Vagal nerve stimulation (VNS) (DEVICE).
Who is sponsoring clinical trial NCT03953768?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Epilepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03953768's enrollment target sits among peer trials
30 109th of 160 higher than 41 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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