VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT03953768
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Diseases
  • Autonomic Dysfunction
  • Epilepsy
  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
0 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Vagal nerve stimulation (VNS) — DEVICE
    Implantation with vagal nerve stimulator for epilepsy

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Nov 2024
Primary completion
Dec 13, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Metagenomic microbiome profile [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Norton HealthcareLouisvilleKentucky40202
Ian S Mutchnick
[email protected]
5023225714
Nora Howerton
[email protected]
5025831697
University of LouisvilleLouisvilleKentucky40202
Ian Mutchnick, MD
[email protected]
5026295512
Texas Children's HospitalHoustonTexas77030-
Primary Children's Hospital/University of UtahSalt Lake CityUtah84113
Rob Bollo, MD
[email protected]
(801) 662-1000
Rob Bollo, MD

Find similar trials in Louisville, KY

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Norton Healthcare· Louisville, KYUniversity of Louisville· Louisville, KYTexas Children's Hospital· Houston, TXPrimary Children's Hospital/University of Utah· Salt Lake City, UT

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