NCT03953768Recruiting
VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems
Prospective Non-randomized Single-arm Trial of Efferent Neuromodulation Immune and Gastrointestinal Systems by VNS in the Epilepsy Population
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 15 Apr 2019
- Start date
- 1 Apr 2021
- Primary completion date
- 13 Dec 2025
- Lead sponsor
- University of Louisville
- Diseases
- Epilepsy
- NCT number
- NCT03953768
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Apr 2021 to the primary completion date, 13 Dec 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with VNS (other than the one implanted for this study)
- Current pregnancy (contraindication to surgery)
- 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.
- 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.
- 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.
- 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.
- Treatment with antiarrhythmic or (heart) rate controlling medication,
Other illness
- Active infection
- History of cancer or treatment with chemotherapy
- Pre-existing cardiac arrhythmia or presence of cardiac pacemaker / defibrillator
Who the study is looking for
- 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.
Age in the registry: 0 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Norton Healthcare Coordinator of this site? Confirm its status | Louisville | United States | Not yet recruiting |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Primary Children's Hospital/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.