Recruiting

VNS

Sponsor:

University of Louisville

Code:

NCT03953768

Conditions

Autoimmune Diseases

Epilepsy

Autonomic Dysfunction

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

Interventions

Vagal nerve stimulation (VNS)

Study Details

Brief 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

Autoimmune Diseases

Epilepsy

Autonomic Dysfunction

Inflammatory Bowel Diseases

Study ID

NCT03953768

Start date

Apr 1, 2021

Status verified date

Nov, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 13, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Patients undergoing device implantation

Patients undergoing device implantation with vagal nerve stimulator (VNS) for epilepsy

Interventions

Vagal nerve stimulation (VNS)

Implantation with vagal nerve stimulator for epilepsy

Primary outcome measure

  • Metagenomic microbiome profile [ Time Frame: 1 year ]
  • Bowel movement frequency [ Time Frame: 1 year ]
  • Bowel habits [ Time Frame: 1 year ]
  • Immune Profile 1 - Flow cytometric profiling of cell populations [ Time Frame: 1 year ]
  • Immune Profile 2 - Ex vivo stimulation of cells in whole blood [ Time Frame: 1 year ]
  • Inflammatory Profile 1 - Meso Scale Discovery (or MSD) analysis for pro-inflammatory cytokines/chemokines [ Time Frame: 1 year ]
  • Inflammatory Profile 2 - Meso Scale Discovery (or MSD) analysis for metabolic hormones [ Time Frame: 1 year ]
  • Inflammatory Profile 3 - Metabolomics for Short Chain Fatty acids (SCFAs) [ Time Frame: 1 year ]
  • Inflammatory Profile 4 - Intestinal inflammation and permeability markers [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ian S Mutchnick, MD

5026295512ianmutchnick@gmail.com

Meena A Vessell, MD

mavessel@texaschildrens.org

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Ian Mutchnick, MD

5026295512ianmutchnick@gmail.com

Primary Children's Hospital/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Rob Bollo, MD

(801) 662-1000robert.bollo@hsc.utah.edu

More Information

Sponsor

University of Louisville

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • epilepsy
  • vagal
  • autoimmune
  • autonomic
  • inflammatory bowel disease
  • immune

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-11-25.