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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 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.
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.
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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