Prospective Non-randomized Single-arm Trial of Efferent Neuromodulation Immune and Gastrointestinal Systems by VNS in the Epilepsy Population

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
Kentucky
Norton Healthcare
NOT_YET_RECRUITING
Louisville
University of Louisville
RECRUITING
Louisville
Texas
Texas Children's Hospital
ACTIVE_NOT_RECRUITING
Houston
Utah
Primary Children's Hospital/University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Ian S Mutchnick, MD
ianmutchnick@gmail.com
5026295512
Backup
Meena A Vessell, MD
mavessel@texaschildrens.org
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Patients undergoing device implantation
Patients undergoing device implantation with vagal nerve stimulator (VNS) for epilepsy
Related Therapeutic Areas
Sponsors
Collaborators: Norton Foundation, LivaNova
Leads: University of Louisville

This content was sourced from clinicaltrials.gov

Similar Clinical Trials