IBD (general)Recruiting
VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
Not applicable · Testing Vagal nerve stimulation (VNS) · 4 sites · University of Louisville
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vagal nerve stimulation (VNS) (a device). Condition(s) listed: Autoimmune Diseases, Epilepsy and Autonomic Dysfunction.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 0 to 60
- Any sex
Some of the main requirements, copied from the record:
- Undergoing VNS implantation for the first time as a treatment for epilepsy and
- 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.
- 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.
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2021-04-01.
- Main results expected around 2025-12-13 (estimate from the record).
- 4 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- Metagenomic microbiome profile (1 year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Autoimmune Diseases; Epilepsy; Autonomic Dysfunction; Inflammatory Bowel Diseases |
| Lead sponsor | University of Louisville |
| Collaborators | LivaNova; Norton Healthcare |
| Enrollment | 30 (estimated) |
| Start date | 2021-04-01 |
| Primary completion (est.) | 2025-12-13 |
| First posted | 2019-05-17 |
| Last updated | 2024-11-25 |
| Official title | Prospective Non-randomized Single-arm Trial of Efferent Neuromodulation Immune and Gastrointestinal Systems by VNS in the Epilepsy Population |
| ClinicalTrials.gov ID | NCT03953768 |
Interventions
- Vagal nerve stimulation (VNS) (Device)
Implantation with vagal nerve stimulator for epilepsy
Full eligibility criteria (from the record)
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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.