VNS Prospective Neuromodulation of Autonomic, Immune and Gastrointestinal Systems — VNSAIG  

Epilepsy Clinical Trial

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

Status Recruiting

Clinical Trial 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 efficacy 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, gastrointestinal and autonomic systems. The primary objective of this study is to characterize the pre- and post-operative bowel habits and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre- and post-operative autonomic profile, (2) characterize the pre- and post-operative immune profile, and (3) to elucidate whether gut microbiota changes are related to VNS efficacy for epilepsy.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Epilepsy
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Primary Dysautonomias

• NCT number: NCT03953768
• Study type: Interventional
• Source: University of Louisville
• Contact: Ian S Mutchnick, MD
• Phone: 502-629-5510
• Email: ianmutchnick@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Completion date: December 14, 2026